Trial Outcomes & Findings for Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis (NCT NCT00195663)

NCT ID: NCT00195663

Last Updated: 2013-07-12

Results Overview

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); * Acute phase reactant value (C-Reactive Protein). Participants who withdrew early were considered non-responders.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 799 participants
• Primary outcome timeframe: Baseline and 52 Weeks
• Results posted on: 2013-07-12

Participant Flow

Patients were enrolled at 94 sites in 15 countries between January 2001 and April 2004.

Patients who had been receiving a previous disease-modifying anti-rheumatic drug (DMARD) participated in a 4-week washout period during which the DMARD was withdrawn. Otherwise, there was a one-week washout period after the Screening visit.

Participant milestones

Measure	Methotrexate Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
2-year Double-blind Treatment Period STARTED	257	274	268
2-year Double-blind Treatment Period COMPLETED	164	166	196
2-year Double-blind Treatment Period NOT COMPLETED	93	108	72
Open-Label Extension Period STARTED	155	159	183
Open-Label Extension Period COMPLETED	79	85	86
Open-Label Extension Period NOT COMPLETED	76	74	97

Reasons for withdrawal

Measure	Methotrexate Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
2-year Double-blind Treatment Period Adverse Event	21	27	32
2-year Double-blind Treatment Period Death	0	2	0
2-year Double-blind Treatment Period Lost to Follow-up	0	0	1
2-year Double-blind Treatment Period Withdrawal by Subject	15	18	12
2-year Double-blind Treatment Period Lack of Efficacy	47	52	13
2-year Double-blind Treatment Period Protocol Violation	6	6	4
2-year Double-blind Treatment Period Planned selection criteria	0	1	0
2-year Double-blind Treatment Period Recovery	1	0	1
2-year Double-blind Treatment Period Administrative reasons	3	2	9
Open-Label Extension Period Adverse Event	21	32	36
Open-Label Extension Period Lost to Follow-up	9	2	6
Open-Label Extension Period Recovery	0	2	2
Open-Label Extension Period Protocol Violation	3	4	4
Open-Label Extension Period Death	2	2	2
Open-Label Extension Period Withdrawal by Subject	16	15	22
Open-Label Extension Period Lack of Efficacy	14	6	12
Open-Label Extension Period Administrative reasons	11	11	13

Baseline Characteristics

Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.	Total n=799 Participants Total of all reporting groups
Age Continuous	52.0 years STANDARD_DEVIATION 13.1 • n=5 Participants	52.1 years STANDARD_DEVIATION 13.5 • n=7 Participants	51.9 years STANDARD_DEVIATION 14.0 • n=5 Participants	52.0 years STANDARD_DEVIATION 13.5 • n=4 Participants
Sex: Female, Male Female	190 Participants n=5 Participants	212 Participants n=7 Participants	193 Participants n=5 Participants	595 Participants n=4 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	62 Participants n=7 Participants	75 Participants n=5 Participants	204 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 52 Weeks

Population: The Full Analysis Set consisted of all patients who were randomized and who received at least one dose of double-blinded study medication. Participants with insufficient data to calculate ACR50 at Week 52 or who withdrew early were considered non-responders.

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;
• ≥ 50% improvement in swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI));
• Acute phase reactant value (C-Reactive Protein).

Participants who withdrew early were considered non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52	118 participants	113 participants	165 participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.

The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 52 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52	5.7 units on a scale Standard Deviation 12.7 • Interval -58.0 to 78.5	3.0 units on a scale Standard Deviation 11.2	1.3 units on a scale Standard Deviation 6.5 • Interval -68.0 to 29.5

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set with available data.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.

Outcome measures

Measure	Methotrexate n=191 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=191 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=213 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52	-0.8 units on a scale Standard Deviation 0.6	-0.8 units on a scale Standard Deviation 0.7	-1.1 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: Full analysis set. Participants with insufficient data to calculate ACR50 at Week 104 or who withdrew early were considered non-responders.

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;
• ≥ 50% improvement in swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Participants withdrawing early were considered non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104	110 participants	101 participants	158 participants

SECONDARY outcome

Timeframe: Baseline and Week 104

Population: Full analysis set. For participants with missing data, mTSS was imputed by linear extrapolation.

The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 104 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104	10.4 units on a scale Standard Deviation 21.7	5.5 units on a scale Standard Deviation 15.8	1.9 units on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: Week 52

Population: Full analysis set. Participants with insufficient data to calculate DAS28 at Week 52 or who withdrew early were considered non-responders.

The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52	53 participants	64 participants	115 participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set with available data.

The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.

Outcome measures

Measure	Methotrexate n=181 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=181 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=198 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52	12.5 units on a scale Standard Deviation 9.6	12.6 units on a scale Standard Deviation 10.0	16.7 units on a scale Standard Deviation 10.2

SECONDARY outcome

Timeframe: Any 6 continuous months from Baseline to Week 104

Population: Full analysis set.

Major clinical response was defined as an American College of Rheumatology 70% (ACR70) response for any six continuous months, over 104 weeks of treatment. A participant was a responder if the following criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Participants withdrawing early were non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With Major Clinical Response After 104 Weeks of Treatment	70 participants	67 participants	130 participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set with available data.

The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.

Outcome measures

Measure	Methotrexate n=181 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=181 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=198 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52	6.5 units on a scale Standard Deviation 11.0	7.1 units on a scale Standard Deviation 12.3	7.2 units on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: Baseline and Weeks 26 and 76

Population: Full analysis set. Participants with insufficient data to calculate ACR50 or who withdrew early were considered non-responders.

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;
• ≥ 50% improvement in swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Participants withdrawing early were considered non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76 Week 26	104 participants	96 participants	157 participants
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76 Week 76	114 participants	114 participants	161 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, 76, and 104

Population: Full analysis set. Participants with insufficient data to calculate ACR20 or who withdrew early were considered non-responders.

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 20% improvement in tender joint count;
• ≥ 20% improvement in swollen joint count; and
• ≥ 20% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Participants withdrawing early were considered non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase Week 26	158 participants	146 participants	184 participants
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase Week 52	161 participants	149 participants	195 participants
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase Week 76	154 participants	137 participants	185 participants
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase Week 104	144 participants	135 participants	186 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, 76, and 104

Population: Full analysis set. Participants with insufficient data to calculate ACR70 or who withdrew early were considered non-responders.

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Participants withdrawing early were considered non-responders.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase Week 104	73 participants	77 participants	125 participants
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase Week 26	57 participants	54 participants	114 participants
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase Week 52	70 participants	71 participants	122 participants
Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase Week 76	75 participants	79 participants	127 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 26, 76, and 104

Population: Full analysis set with available data.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase Week 12 [N=236, 246, 252]	-0.6 units on a scale Standard Deviation 0.6	-0.6 units on a scale Standard Deviation 0.6	-0.8 units on a scale Standard Deviation 0.6
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase Week 26 [N=217, 222, 240]	-0.8 units on a scale Standard Deviation 0.6	-0.8 units on a scale Standard Deviation 0.7	-0.9 units on a scale Standard Deviation 0.6
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase Week 76 [N= 176, 175, 207]	-0.8 units on a scale Standard Deviation 0.6	-0.9 units on a scale Standard Deviation 0.7	-1.0 units on a scale Standard Deviation 0.7
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase Week 104 [166, 162, 201]	-0.9 units on a scale Standard Deviation 0.6	-0.9 units on a scale Standard Deviation 0.6	-1.0 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, 76, and 104

Population: Full analysis set. Missing values were considered to be \< 0.3.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase Week 104	137 participants	132 participants	171 participants
Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase Week 26	172 participants	169 participants	200 participants
Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase Week 52	158 participants	151 participants	186 participants
Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase Week 76	144 participants	145 participants	173 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, and 104

Population: Full analysis set with available data.

The HUI 2/3 is an assessment of various aspects of participants' health and ability to perform various tasks on a day-to-day basis, including reading, seeing, hearing, speaking, general outlook on life, pain/discomfort, ability to walk, use of hands, memory, ability to think/solve, and ability to perform basic activities such as eating, bathing, and dressing. The HUI 2/3 is a combined 15-item questionnaire based on a recall period of the previous 4 weeks. HUI-2 and HUI-3 scores are calculated independently. The HUI-2 score includes 6 attributes: Sensation, Mobility, Emotion, Cognition, Self-Care, and Pain. The HUI-3 score is comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain.

The range of each score is from 0 (dead) to 1 (perfect health). An increase from Baseline indicates improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-2: Week 26 [N=192, 187, 205]	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-2: Week 52 [N=179, 162, 189]	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-2: Week 104 [N=152, 136, 174]	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2	0.2 units on a scale Standard Deviation 0.2
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-3: Week 26 [N=192, 189, 205]	0.3 units on a scale Standard Deviation 0.3	0.3 units on a scale Standard Deviation 0.3	0.3 units on a scale Standard Deviation 0.3
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-3: Week 52 [N=177, 164, 190]	0.3 units on a scale Standard Deviation 0.3	0.3 units on a scale Standard Deviation 0.3	0.4 units on a scale Standard Deviation 0.3
Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase HUI-3: Week 104 [N=154, 138, 177]	0.3 units on a scale Standard Deviation 0.2	0.4 units on a scale Standard Deviation 0.3	0.4 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and Weeks 26 and 104

Population: Full analysis set with available data.

The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component and items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); increases from Baseline indicate improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase Physical Component: Week 26 [N=199, 204, 221]	11.2 units on a scale Standard Deviation 10.0	10.8 units on a scale Standard Deviation 10.2	14.7 units on a scale Standard Deviation 10.2
Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase Physical Component: Week 104 [160, 157, 189]	12.4 units on a scale Standard Deviation 10.3	13.4 units on a scale Standard Deviation 9.7	16.8 units on a scale Standard Deviation 11.2
Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase Mental Component: Week 26 [N=199, 204, 221]	7.0 units on a scale Standard Deviation 11.6	5.2 units on a scale Standard Deviation 13.5	6.3 units on a scale Standard Deviation 12.1
Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase Mental Component: Week 104 [N=160, 157, 189]	8.1 units on a scale Standard Deviation 10.9	6.6 units on a scale Standard Deviation 13.5	6.8 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, 76, and 104

Population: Full analysis set with available data.

ACR-N is a composite, continuous variable which measures the percentage of improvement from Baseline in individual participants based on the 7 core set variables of the ACR. ACR-N is defined as the smallest percent change from Baseline of 3 measures: tender joint counts (TJC), swollen joint counts (SJC), and the median percent improvement in the 5 remaining measures (Patient's Assessment of Pain, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Health Assessment Questionnaire - Disability Index [HAQ-DI], and C-Reactive Protein). A positive ACR-N value indicates improvement; a negative ACR-N value indicates worsening; ACR-N of 0 indicates no change.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase Week 26 [N=218, 224, 244]	44.7 percent change Standard Deviation 42.2	39.1 percent change Standard Deviation 43.3	57.0 percent change Standard Deviation 42.2
Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase Week 52 [N=194, 193, 220]	50.2 percent change Standard Deviation 48.2	44.4 percent change Standard Deviation 52.2	66.3 percent change Standard Deviation 34.8
Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase Week 76 [N=181, 179, 211]	56.1 percent change Standard Deviation 38.1	51.5 percent change Standard Deviation 56.8	68.8 percent change Standard Deviation 31.3
Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase Week 104 [N=168, 167, 203]	57.3 percent change Standard Deviation 37.1	54.0 percent change Standard Deviation 42.7	71.4 percent change Standard Deviation 31.0

SECONDARY outcome

Timeframe: Baseline and Weeks 26, 52, 76, and 104

Population: Full analysis set with available data.

The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:

• 28 tender joint counts,
• 28 swollen joint counts,
• C-reactive protein, and
• Patient's global assessment of disease activity.

Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase Week 26 [N=209, 218, 229]	-2.6 units on a scale Standard Deviation 1.3	-2.4 units on a scale Standard Deviation 1.4	-3.2 units on a scale Standard Deviation 1.3
Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase Week 52 [N=184, 185, 206]	-2.8 units on a scale Standard Deviation 1.4	-2.8 units on a scale Standard Deviation 1.5	-3.6 units on a scale Standard Deviation 1.3
Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase Week 76 [N=173, 173, 197]	-3.1 units on a scale Standard Deviation 1.2	-3.0 units on a scale Standard Deviation 1.5	-3.7 units on a scale Standard Deviation 1.3
Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase Week 104 [N=161, 158, 191]	-3.1 units on a scale Standard Deviation 1.4	-3.2 units on a scale Standard Deviation 1.4	-3.8 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline and Weeks 52 and 104

Population: Full analysis set. Missing values were imputed.

Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21-40% joint involvement; 3 = 3 separate quadrants with erosion or 41-60% joint involvement; 4 = all 4 quadrants with erosion or 61-80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion)to 230 (worst). A large increase in erosion score is indicative of worsening, whereas a small change or no change is indicative of inhibition of joint erosion.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period Week 52	3.7 units on a scale Standard Deviation 8.4	1.7 units on a scale Standard Deviation 5.7	0.8 units on a scale Standard Deviation 3.3
Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period Week 104	6.4 units on a scale Standard Deviation 14.3	3.0 units on a scale Standard Deviation 8.3	1.0 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: Baseline and Weeks 52 and 104

Population: Full analysis set. Missing values were imputed.

Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joint space narrowing (JSN) scores were recorded for each hand/wrist (16 joints) and each forefoot (5 joints) on a 5-point scale (0 = no narrowing; 1 = up to 25% narrowing; 2 = 26-65% narrowing; 3 = 66-99% narrowing; and 4 = complete narrowing). Scores were summed to calculate the total score ranging from 0 (no narrowing) to 168 (maximum narrowing). A large increase in joint narrowing score is indicative of worsening, whereas a small change or no change is indicative of inhibition of JSN.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period Week 52	2.0 units on a scale Standard Deviation 6.3	1.3 units on a scale Standard Deviation 6.6	0.5 units on a scale Standard Deviation 4.2
Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period Week 104	4.0 units on a scale Standard Deviation 10.9	2.6 units on a scale Standard Deviation 9.5	0.9 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Baseline and Weeks 52 and 104

Population: Full analysis set. Participants with missing data or who withdrew early were considered non-responders.

The number of participants with no worsening in the modified Total Sharp Score (mTSS) and in erosion and joint space narrowing (JSN) scores, where no worsening is defined as a change from Baseline of ≤ 0 in mTSS, erosion score and JSN score, at Weeks 52 and 104.

Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Outcome measures

Measure	Methotrexate n=257 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Modified Total Sharp Score: Week 52	78 participants	112 participants	141 participants
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Modified Total Sharp Score: Week 104	70 participants	105 participants	136 participants
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Erosion Scoe: Week 52	91 participants	133 participants	158 participants
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Erosion Score: Week 104	81 participants	121 participants	148 participants
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Joint Space Narrowing Score: Week 52	127 participants	159 participants	190 participants
Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase Joint Space Narrowing Score: Week 104	112 participants	147 participants	175 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 52 and 104

Population: Full analysis set participants with no erosions at Baseline and non-missing data.

The number of participants with no erosions at Baseline and no erosions at Weeks 52 and 104, where no erosions and no new erosions are defined as an erosion score = 0.

Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints on each hand/wrist (17 joints) and each forefoot (6 joints) were scored for erosions on a scale of 0 = no erosions; 1 = 1 discrete erosion or ≤20% joint involvement; 2 = 2 separate quadrants with erosion or 21-40% joint involvement; 3 = 3 separate quadrants with erosion or 41-60% joint involvement; 4 = all 4 quadrants with erosion or 61-80% joint involvement; and 5 = extensive destruction with >80% joint involvement. Scores were summed to calculate the total erosion score, which ranges from 0 (no erosion) to 230 (worst).

Outcome measures

Measure	Methotrexate n=11 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=16 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=20 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104 Week 52	8 participants	10 participants	13 participants
Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104 Week 104	7 participants	8 participants	11 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 52 and 104

Population: Full analysis set participants with non-involved joints at Baseline and non-missing data.

Number of participants with non-involved joints at Baseline and no newly involved joints at Weeks 52 and 104, where involved joints or no newly involved joints are defined as modified Total Sharp Score (mTSS) = 0.

Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]).

Outcome measures

Measure	Methotrexate n=5 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=14 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=16 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104 Week 104	3 participants	7 participants	9 participants
Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104 Week 52	4 participants	9 participants	12 participants

SECONDARY outcome

Timeframe: Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.

Population: Intent-to-treat (ITT) Analysis Set (all patients who received at least 1 dose of adalimumab during the study, including patients who received their first dose during the DB phase and those who received MTX during the DB phase and adalimumab in the OL phase) with available ACR data. "N" indicates patients with non-missing data at each time point.

American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 20% improvement in tender joint count;
• ≥ 20% improvement in swollen joint count; and
• ≥ 20% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Baseline is the last value prior to the first dose of adalimumab. For participants randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase.

Outcome measures

Measure	Methotrexate n=687 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure Year 1 [N=410]	340 participants	—	—
Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure Year 2 [N=385]	332 participants	—	—
Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure Year 5 [N=325]	231 participants	—	—
Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure Year 10 [N=170]	154 participants	—	—

SECONDARY outcome

Timeframe: Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.

Population: ITT Analysis Set with available ACR data. "N" indicates patients with non-missing data at each time point.

American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 50% improvement in tender joint count;
• ≥ 50% improvement in swollen joint count; and
• ≥ 50% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase.

Outcome measures

Measure	Methotrexate n=687 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure Year 10 [N=170]	127 participants	—	—
Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure Year 1 [N=410]	269 participants	—	—
Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure Year 2 [N=385]	266 participants	—	—
Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure Year 5 [N=325]	194 participants	—	—

SECONDARY outcome

Timeframe: Baseline and after 1, 2, 5, and 10 years of adalimumab exposure. Baseline was the last value prior to the first dose of adalimumab.

Population: ITT Analysis Set with available data. "N" indicates patients with non-missing data at each time point.

American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Baseline is the last value prior to the first dose of adalimumab. For patients randomized to the methotrexate (MTX) arm in the double-blind (DB) phase, Baseline was the last visit prior to the first adalimumab dose at Week 106 of the open-label (OL) phase.

Outcome measures

Measure	Methotrexate n=687 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure Year 1 [N=410]	186 participants	—	—
Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure Year 2 [N=385]	207 participants	—	—
Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure Year 5 [N=325]	153 participants	—	—
Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure Year 10 [N=170]	102 participants	—	—

SECONDARY outcome

Timeframe: Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.

Population: ITT Analysis Set, with available data. "N" indicates patients with non-missing data at each time point.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement.

Outcome measures

Measure	Methotrexate n=692 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure Year 1 [N=407]	-0.9 units on a scale Standard Deviation 0.68	—	—
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure Year 2 [N=390]	-0.9 units on a scale Standard Deviation 0.70	—	—
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure Year 5 [N=344]	-0.7 units on a scale Standard Deviation 0.73	—	—
Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure Year 10 [N=170]	-0.9 units on a scale Standard Deviation 0.73	—	—

SECONDARY outcome

Timeframe: Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.

Population: ITT Analysis Set, with available data. "N" indicates patients with non-missing data at Baseline and the specified time point.

The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:

• 28 tender joint counts,
• 28 swollen joint counts,
• C-reactive protein, and
• Patient's global assessment of disease activity.

Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Methotrexate n=689 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure Year 1 [N=403]	-3.2 units on a scale Standard Deviation 1.49	—	—
Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure Year 2 [N=386]	-3.3 units on a scale Standard Deviation 1.61	—	—
Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure Year 5 [N=330]	-2.8 units on a scale Standard Deviation 1.93	—	—
Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure Year 10 [N=158]	-3.9 units on a scale Standard Deviation 1.29	—	—

SECONDARY outcome

Timeframe: After 1, 2, 5, and 10 years of adalimumab exposure

Population: ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing DAS28 scores at any post-baseline time point; "N" indicates patients with non-missing data at each specified time point.

The DAS28 is a composite score of rheumatoid arthritis disease activity derived from the following variables:

• 28 tender joint counts,
• 28 swollen joint counts,
• C-reactive protein, and
• Patient's global assessment of disease activity.

Scores on the DAS28 range from 0 to 10. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Methotrexate n=694 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=694 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure Year 2 [N=389]	215 participants	271 participants	—
Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure Year 1 [N=405]	173 participants	244 participants	—
Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure Year 5 [N=333]	190 participants	244 participants	—
Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure Year 10 [N=159]	109 participants	135 participants	—

SECONDARY outcome

Timeframe: Baseline (prior to first study drug treatment) and Years 2 and 10

Population: ITT Analysis Set, with available data. "N" indicates patients with non-missing radiographic data at each time point.

The modified TSS (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

Outcome measures

Measure	Methotrexate n=83 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=93 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=90 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years Year 2 [N=83, 92, 89]	6.3 units on a scale Standard Deviation 12.44	5.1 units on a scale Standard Deviation 9.63	0.3 units on a scale Standard Deviation 3.00
Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years Year 10 [N= 83, 93, 90]	10.8 units on a scale Standard Deviation 20.01	9.2 units on a scale Standard Deviation 15.21	3.9 units on a scale Standard Deviation 9.64

SECONDARY outcome

Timeframe: Baseline (prior to first study drug treatment) and Years 2 and 10.

Population: ITT Analysis Set, with available data. "N" indicates patients with non-missing radiographic data at each time point.

The modified Total Sharp Score (mTSS) is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and during the study were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement. The number of participants with change from Baseline ≤ 0.5 and ≤ 0 is reported as a measure of no disease progression.

Outcome measures

Measure	Methotrexate n=83 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=93 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=90 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With No Radiographic Progression Over 10 Years Change ≤ 0 at Year 10 [N=83, 93, 90]	19 participants	16 participants	29 participants
Number of Participants With No Radiographic Progression Over 10 Years Change ≤ 0.5 at Year 2 [N=83, 92, 89]	36 participants	40 participants	65 participants
Number of Participants With No Radiographic Progression Over 10 Years Change ≤ 0.5 at Year 10 [N=83, 93, 90]	26 participants	22 participants	33 participants
Number of Participants With No Radiographic Progression Over 10 Years Change ≤ 0 at Year 2 [N=83, 92, 89]	22 participants	30 participants	51 participants

SECONDARY outcome

Timeframe: Year 10

Population: This outcome measure was not analyzed due to a protocol amendment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the first dose of adalimumab (at Week 1 or Week 106 for patients initially randomized to methotrexate in the DB phase) to Year 10

Population: ITT Analysis Set for participants with non-missing ACR data.

A major clinical response was defined as maintenance of an ACR70 response for at least a 6-month continuous period at any time during the study following the first dose of adalimumab. A participant was a responder if the following criteria for improvement from Baseline were met:

• ≥ 70% improvement in tender joint count;
• ≥ 70% improvement in swollen joint count; and
• ≥ 70% improvement in at least 3 of the 5 following parameters:

• Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
• Patient's global assessment of disease activity (measured on a 100 mm VAS);
• Physician's global assessment of disease activity (measured on a 100 mm VAS);
• Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
• Acute phase reactant value (C-Reactive Protein).

Outcome measures

Measure	Methotrexate n=687 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure	273 participants	—	—

SECONDARY outcome

Timeframe: Baseline and Years 1, 2, 5, and 10. Baseline was the last value prior to the first dose of adalimumab. For patients randomized to the MTX arm in the DB phase, Baseline was the last visit prior to the first adalimumab dose at Week 106.

Population: ITT Analysis Set, with available data. The Number of Participants Analyzed indicates patients with non-missing HAQ-DI scores at any post-baseline time point; "N" indicates patients with non-missing data at each specified time point.

The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A decrease in the HAQ-DI score represents an improvement in physical function; a clinically significant improvement is defined as a decrease of least 0.22 from Baseline in the HAQ-DI score. The number of participants with improvement in HAQ-DI of at least 0.22 and 0.5 units from Baseline is reported.

Outcome measures

Measure	Methotrexate n=692 Participants Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=692 Participants Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure Year 1 [N=407]	353 participants	285 participants	—
Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure Year 2 [N=390]	324 participants	265 participants	—
Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure Year 5 [N=344]	239 participants	188 participants	—
Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure Year 10 [N=170]	140 participants	112 participants	—

Adverse Events

Methotrexate

Serious events: 47 serious events

Other events: 227 other events

Deaths: 0 deaths

Adalimumab

Serious events: 65 serious events

Other events: 227 other events

Deaths: 0 deaths

Adalimumab + Methotrexate

Serious events: 56 serious events

Other events: 241 other events

Deaths: 0 deaths

Any Adalimumab

Serious events: 320 serious events

Other events: 634 other events

Deaths: 0 deaths

Serious adverse events

Measure	Methotrexate n=257 participants at risk Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 participants at risk Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 participants at risk Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Any Adalimumab n=697 participants at risk Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week. Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years).
Blood and lymphatic system disorders Anaemia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.86% 6/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Lymphadenopathy	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Pancytopenia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Acute coronary syndrome	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Acute myocardial infarction	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Angina pectoris	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Angina unstable	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Arrhythmia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Atrial fibrillation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 8/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Atrial Flutter	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Atrioventricular block	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Bradycardia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Cardiac arrest	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Cardiac failure congestive	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Cardiac failure	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Cardiac tamponade	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Coronary artery disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Coronary artery occlusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Coronary artery stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Mitral valve stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Myocardial infarction	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.0% 7/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Myocardial ischaemia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Pericarditis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Pleuropericarditis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Right ventricular failure	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Sinoatrial block	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Cardiac disorders Tachyarrhythmia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Ear and labyrinth disorders Hearing impaired	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Ear and labyrinth disorders Otosclerosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Endocrine disorders Goitre	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Endocrine disorders Hyperthyroidism	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Blindness	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Blindness unilateral	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Cataract	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Corneal disorder	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Corneal opacity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Keratitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Necrotising scleritis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Ocular hypertension	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Vitreous detachment	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Retinal detachment	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Retinal disorder	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Vitreous haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal hernia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal mass	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal wall cyst	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Acute abdomen	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Colitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Colitis ischaemic	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Colonic polyp	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Constipation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Crohn's Disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Diverticulum	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Dyspepsia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Gastritis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Haemorrhoids	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Ileus	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Ileus paralytic	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Inguinal hernia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Intestinal obstruction	0.78% 2/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Large intestine perforation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Melaena	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Nausea	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Obstruction gastric	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Oesophageal achalasia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Pancreatitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Vomiting	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Asthenia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Calcinosis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Chest pain	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Death	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Device dislocation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Drug ineffective	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Dysplasia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Impaired healing	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Medical device complication	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Multi-organ failure	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Non-cardiac chest pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Oedema	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Oedema peripheral	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Pyrexia	0.78% 2/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Stent-graft endoleak	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Sudden cardiac death	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Bile duct stone	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Cholangitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Cholecystitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Cholelithiasis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 3/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 8/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Hepatobiliary disorders Hepatic necrosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Immune system disorders Anaphylactic reaction	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Immune system disorders Anaphylactic shock	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Immune system disorders Drug Hypersensitivity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Immune system disorders Hypersensitivity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Immune system disorders Seasonal allergy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Abscess	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Abdominal abscess	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Appendicitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Appendicitis perforated	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Arthritis bacterial	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bacterial sepsis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bartholin's abscess	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bronchitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bronchopneumonia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bursitis infective	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Cellulitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Chronic sinusitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Clostridium difficile colitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Corneal abscess	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Disseminated tuberculosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Diverticulitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Eczema infected	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Endocarditis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Epstein-barr virus infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Erysipelas	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Extradural abscess	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Gastroenteritis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Gastroenteritis salmonella	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Groin abscess	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Helicobacter infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Hepatitis B	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Infectious pleural effusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Kidney infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Lobar pneumonia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Localised infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Lower respiratory tract infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Meningitis streptococcal	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Mycobacterium marinum infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Neurological infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Otitis media	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Parotitis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Pneumonia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.2% 15/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Pneumonia legionella	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Pneumonia pneumococcal	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Pyelonephritis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Respiratory tract infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Sepsis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Septic shock	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Sinusitis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Tuberculosis gastrointestinal	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Tuberculous pleurisy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Urinary tract infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Urosepsis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Wound infection	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Injury	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Concussion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Contusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Excoriation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Fall	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Humerus fracture	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Laceration	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Overdose	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Post-operative wound complication	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Road traffic accident	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Subcutaneous haematoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Testicular injury	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Alanine aminotransferase increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Aspartate aminotransferase increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Blood creatine phosphokinase increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Blood culture positive	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Blood pressure increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations CSF pressure increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Haemoglobin decreased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Heart rate increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Hepatitis c antibody positive	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations International normalised ratio increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Intraocular pressure increased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Weight decreased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Dehydration	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Gout	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Malnutrition	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Obesity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.0% 7/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Bone erosion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Bone fistula	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Bone pain	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 8/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.0% 7/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Joint destruction	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Knee deformity	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.78% 2/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 3/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 23/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Osteoporosis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.3% 6/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.8% 16/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 3/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 38/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Synovitis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell small lymphocytic lymphoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer stage II	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage 0	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma cutis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Enchondromatosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hair follicle tumour benign	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Histiocytosis haematophagic	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage III	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-hodgkin's lymphoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.72% 5/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Cerebral ischaemia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Cerebrovascular accident	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Cervical myelopathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Clonus	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Dementia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Dementia alzheimer's type	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Dizziness	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Encephalopathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Hepatic encephalopathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Hyperreflexia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Intention tremor	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Nerve compression	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Optic neuritis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Paraesthesia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Sciatica	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Syncope	0.78% 2/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.0% 7/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Transient ischaemic attack	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.73% 2/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Alcohol abuse	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Bipolar disorder	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Delirium	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Depression	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Depression suicidal	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Mental status changes	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Nephrolithiasis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.86% 6/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Calculus Ureteric	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Calculus urinary	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Renal failure	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Renal failure acute	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Renal haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Renal mass	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Urethral stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Renal and urinary disorders Urinary incontinence	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Cervical dysplasia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Dyspareunia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Endometriosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Menometrorrhagia	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Menorrhagia	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Menstruation irregular	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Uterine cyst	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Uterine prolapse	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Uterovaginal prolapse	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Reproductive system and breast disorders Vaginal prolapse	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.86% 6/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.43% 3/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Vocal cord cyst	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Rash	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Surgical and medical procedures Abortion induced	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Surgical and medical procedures Foot operation	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Surgical and medical procedures Female sterilization	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Aortic aneurysm	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Aortic stenosis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Hypotension	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Aortitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Deep vein thrombosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.57% 4/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Femoral artery occlusion	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Haematoma	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Haemorrhage	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Hypertensive crisis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Iliac artery stenosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Rheumatoid vasculitis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.36% 1/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Thrombosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Varicose vein	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.37% 1/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.29% 2/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Vasculitis	0.39% 1/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Venous thrombosis	0.00% 0/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.14% 1/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.

Other adverse events

Measure	Methotrexate n=257 participants at risk Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Adalimumab n=274 participants at risk Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.	Adalimumab + Methotrexate n=268 participants at risk Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.	Any Adalimumab n=697 participants at risk Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week. Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years).
Eye disorders Conjunctivitis	1.2% 3/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.2% 6/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.7% 10/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.2% 36/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Anaemia	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.7% 13/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 43/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Blood and lymphatic system disorders Lymphadenopathy	4.7% 12/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 15/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.00% 0/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 28/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Ear and labyrinth disorders Vertigo	3.5% 9/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.1% 14/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.9% 5/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.0% 42/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Eye disorders Cataract	1.9% 5/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.8% 5/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.2% 6/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.6% 39/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal pain	3.5% 9/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 11/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.5% 12/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.6% 46/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Nausea	20.6% 53/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	17.5% 48/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	17.2% 46/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	18.8% 131/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Dyspepsia	10.1% 26/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.3% 20/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.3% 25/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.6% 74/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Diarrhoea	16.3% 42/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.7% 32/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.4% 28/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.1% 105/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Abdominal pain upper	8.6% 22/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.9% 19/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.0% 24/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.0% 77/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Vomiting	4.7% 12/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.4% 12/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.2% 14/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.3% 44/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Mouth ulceration	5.8% 15/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.6% 7/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.5% 12/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.6% 25/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Constipation	6.6% 17/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.1% 3/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.1% 11/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.7% 33/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Chest pain	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.7% 13/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.5% 12/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.0% 42/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Fatigue	10.5% 27/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.2% 28/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	12.3% 33/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	14.1% 98/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Oedema peripheral	6.2% 16/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.8% 16/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.7% 18/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.8% 68/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
General disorders Pyrexia	3.5% 9/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 11/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.0% 35/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Nasopharyngitis	24.5% 63/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	22.6% 62/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	30.2% 81/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	31.4% 219/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Gastroenteritis	4.3% 11/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.2% 6/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.4% 9/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 38/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Herpes zoster	0.78% 2/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.9% 8/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.2% 50/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Upper respiratory tract infection	18.3% 47/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.8% 24/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	18.7% 50/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	25.3% 176/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Pharyngitis	4.3% 11/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.7% 10/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 43/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Respiratory tract infection	1.2% 3/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.6% 10/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.0% 8/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 38/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Rhinitis	4.3% 11/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.1% 14/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.6% 15/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.9% 48/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Sinusitis	6.6% 17/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.4% 23/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.8% 29/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.9% 111/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Oral herpes	3.9% 10/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.8% 5/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.0% 16/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 43/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Urinary tract infection	8.6% 22/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.9% 30/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.8% 21/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	18.9% 132/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Bronchitis	10.9% 28/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.6% 18/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.8% 21/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.6% 109/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Infections and infestations Influenza	7.0% 18/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.7% 21/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.6% 15/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.0% 77/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Contusion	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.8% 5/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.1% 19/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.9% 48/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Injury, poisoning and procedural complications Fall	1.9% 5/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.8% 5/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.7% 10/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.0% 42/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Alanine aminotransferase increased	6.6% 17/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.6% 7/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.8% 29/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.5% 52/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Investigations Aspartate aminotransferase increased	4.3% 11/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.2% 14/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 28/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Metabolism and nutrition disorders Hypercholesterolaemia	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.4% 12/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.8% 61/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Arthralgia	11.3% 29/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	12.4% 34/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.2% 30/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	18.5% 129/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Back pain	11.3% 29/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.3% 31/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.6% 23/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.5% 108/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Bursitis	2.3% 6/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 11/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.7% 10/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.3% 58/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Muscle spasms	2.7% 7/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.5% 12/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.7% 40/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.9% 10/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.9% 5/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.6% 46/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Myalgia	2.3% 6/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	2.2% 6/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.5% 4/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.6% 39/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.6% 4/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	0.75% 2/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.2% 50/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Pain in extremity	4.3% 11/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 11/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.7% 18/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.6% 74/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	14.8% 38/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.7% 43/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.7% 26/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	27.1% 189/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Joint swelling	5.1% 13/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 15/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.9% 5/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.6% 39/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Musculoskeletal and connective tissue disorders Tendonitis	1.9% 5/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.8% 5/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.9% 5/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.9% 41/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Headache	16.3% 42/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	21.5% 59/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	20.5% 55/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	22.2% 155/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Dizziness	5.8% 15/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.5% 26/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.5% 20/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.6% 67/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Nervous system disorders Paraesthesia	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.7% 13/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.0% 8/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.6% 46/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Depression	7.4% 19/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.7% 13/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	7.1% 19/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.9% 69/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Psychiatric disorders Insomnia	2.7% 7/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 17/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.0% 8/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.9% 48/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Cough	9.7% 25/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	12.4% 34/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	11.2% 30/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	15.4% 107/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	3.1% 8/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.8% 16/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.7% 10/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 43/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.4% 19/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.8% 24/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	8.2% 22/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.3% 65/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Alopecia	5.1% 13/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.0% 11/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.7% 18/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.5% 38/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Rash	8.6% 22/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.1% 25/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.3% 17/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	14.1% 98/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Eczema	2.3% 6/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	4.4% 12/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.4% 9/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.2% 43/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Skin and subcutaneous tissue disorders Erythema	1.2% 3/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	1.9% 5/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	5.2% 36/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Vascular disorders Hypertension	12.5% 32/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	9.1% 25/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	10.8% 29/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	22.0% 153/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.3% 6/257 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.3% 9/274 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	3.0% 8/268 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.	6.9% 48/697 • For the double-blind treatment phase, up to 2 years (Methotrexate, Adalimumab and Adalimumab + Methotrexate reporting groups). For the Any Adalimumab reporting group, adverse events include the open-label extension, and are reported for up to 10 years.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER