Trial Outcomes & Findings for Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study (NCT NCT02196701)

NCT ID: NCT02196701

Last Updated: 2018-03-19

Results Overview

Study investigators were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

46 participants

Primary outcome timeframe

Week 16

Results posted on

2018-03-19

Participant Flow

This single-arm, open-label longitudinal study was conducted at 12 sites in Canada from 5 August 2014 to 17 March 2017. The study entailed a screening period up to 35 days, a 24-week treatment period, and a 70-day safety follow-up period. Participants continued to receive adalimumab (ADA) and had oral methotrexate (MTX) added to their treatment.

This study enrolled participants who in the opinion of the Investigator were not responding optimally to adalimumab monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) or who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders).

Participant milestones

Participant milestones
Measure	Adalimumab + Methotrexate Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Overall Study STARTED	46
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Adalimumab + Methotrexate Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1
Overall Study Non-adherence to Protocol	1

Baseline Characteristics

Concomitant Longitudinal Evaluation of Adalimumab With Methotrexate in the Real World: the CLEAR Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Total n=46 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 13.84 • n=5 Participants	47.3 years STANDARD_DEVIATION 11.91 • n=7 Participants	46.5 years STANDARD_DEVIATION 12.20 • n=5 Participants
Age, Customized < 40 years	2 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants
Age, Customized 40 - 64 years	4 Participants n=5 Participants	22 Participants n=7 Participants	26 Participants n=5 Participants
Age, Customized ≥ 65 years	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	31 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	39 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	31 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Duration of Psoriasis	20.623 years STANDARD_DEVIATION 10.4819 • n=5 Participants	21.760 years STANDARD_DEVIATION 9.7403 • n=7 Participants	21.612 years STANDARD_DEVIATION 9.7253 • n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment	33.3 percentage of participants Interval 0.0 to 71.1	52.5 percentage of participants Interval 37.0 to 68.0	50.0 percentage of participants Interval 35.6 to 64.4

PRIMARY outcome

Timeframe: Week 16

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.

Participants were asked to complete the following questionnaire at week 16: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment	16.7 percentage of participants Interval 0.0 to 46.5	52.5 percentage of participants Interval 37.0 to 68.0	47.8 percentage of participants Interval 33.4 to 62.3

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

Study investigators were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time Baseline	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0
Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time Week 8	50.0 percentage of participants Interval 10.0 to 90.0	42.5 percentage of participants Interval 27.2 to 57.8	43.5 percentage of participants Interval 29.2 to 57.8
Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time Week 24	33.3 percentage of participants Interval 0.0 to 71.1	60.0 percentage of participants Interval 44.8 to 75.2	56.5 percentage of participants Interval 42.2 to 70.8

SECONDARY outcome

Timeframe: Baseline, week 8 and week 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

Participants were asked to complete the following questionnaire at each scheduled visit: Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were: * Completely dissatisfied * Moderately dissatisfied * Slightly satisfied * Highly satisfied * Completely satisfied Satisfaction with therapy was defined by the combination of highly or completely satisfied responses.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time Baseline	0 percentage of participants Interval 0.0 to 0.0	17.5 percentage of participants Interval 5.7 to 29.3	15.2 percentage of participants Interval 4.8 to 25.6
Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time Week 8	16.7 percentage of participants Interval 0.0 to 46.5	52.5 percentage of participants Interval 37.0 to 68.0	47.8 percentage of participants Interval 33.4 to 62.3
Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	60.0 percentage of participants Interval 44.8 to 75.2	54.3 percentage of participants Interval 40.0 to 68.7

SECONDARY outcome

Timeframe: Baseline, weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=46 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Missing	1 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Highly satisfied	14 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Slightly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Moderately dissatisfied	9 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Completely satisfied	0 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Highly satisfied	0 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Slightly satisfied	8 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Moderately dissatisfied	31 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Completely dissatisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Baseline · Missing	0 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Completely satisfied	6 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Completely satisfied	11 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Highly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 8 · Completely dissatisfied	1 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Completely satisfied	8 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Highly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Slightly satisfied	10 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Moderately dissatisfied	8 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Completely dissatisfied	3 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 16 · Missing	2 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Slightly satisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Moderately dissatisfied	6 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Completely dissatisfied	4 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time Week 24 · Missing	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=46 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Completely satisfied	5 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Highly satisfied	2 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Slightly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Moderately dissatisfied	17 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Completely dissatisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Baseline · Missing	0 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Completely satisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Completely satisfied	10 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Highly satisfied	12 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Slightly satisfied	14 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Moderately dissatisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Completely dissatisfied	2 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 8 · Missing	1 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Highly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Slightly satisfied	13 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Moderately dissatisfied	6 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Completely dissatisfied	3 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 16 · Missing	2 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Completely satisfied	10 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Highly satisfied	15 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Slightly satisfied	7 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Moderately dissatisfied	6 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Completely dissatisfied	5 Participants	—	—
Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time Week 24 · Missing	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time Week 16	50.0 percentage of participants Interval 10.0 to 90.0	62.5 percentage of participants Interval 47.5 to 77.5	60.9 percentage of participants Interval 46.8 to 75.0
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time Week 24	66.7 percentage of participants Interval 28.9 to 100.0	65.0 percentage of participants Interval 50.2 to 79.8	65.2 percentage of participants Interval 51.5 to 79.0
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time Week 8	50.0 percentage of participants Interval 10.0 to 90.0	42.5 percentage of participants Interval 27.2 to 57.8	43.5 percentage of participants Interval 29.2 to 57.8

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Who Achieved a PASI 75 Response Over Time Week 16	16.7 percentage of participants Interval 0.0 to 46.5	42.5 percentage of participants Interval 27.2 to 57.8	39.1 percentage of participants Interval 25.0 to 53.2
Percentage of Participants Who Achieved a PASI 75 Response Over Time Week 8	33.3 percentage of participants Interval 0.0 to 71.1	27.5 percentage of participants Interval 13.7 to 41.3	28.3 percentage of participants Interval 15.2 to 41.3
Percentage of Participants Who Achieved a PASI 75 Response Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	42.5 percentage of participants Interval 27.2 to 57.8	39.1 percentage of participants Interval 25.0 to 53.2

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Who Achieved a PASI 90 Response Over Time Week 8	16.7 percentage of participants Interval 0.0 to 46.5	12.5 percentage of participants Interval 2.3 to 22.7	13.0 percentage of participants Interval 3.3 to 22.8
Percentage of Participants Who Achieved a PASI 90 Response Over Time Week 16	16.7 percentage of participants Interval 0.0 to 46.5	15.0 percentage of participants Interval 3.9 to 26.1	15.2 percentage of participants Interval 4.8 to 25.6
Percentage of Participants Who Achieved a PASI 90 Response Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	30.0 percentage of participants Interval 15.8 to 44.2	28.3 percentage of participants Interval 15.2 to 41.3

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Who Achieved a PASI 100 Response Over Time Week 8	16.7 percentage of participants Interval 0.0 to 46.5	12.5 percentage of participants Interval 2.3 to 22.7	13.0 percentage of participants Interval 3.3 to 22.8
Percentage of Participants Who Achieved a PASI 100 Response Over Time Week 16	16.7 percentage of participants Interval 0.0 to 46.5	10.0 percentage of participants Interval 0.7 to 19.3	10.9 percentage of participants Interval 1.9 to 19.9
Percentage of Participants Who Achieved a PASI 100 Response Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	27.5 percentage of participants Interval 13.7 to 41.3	26.1 percentage of participants Interval 13.4 to 38.8

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Change From Baseline in PASI Score Over Time Week 16	-4.5 units on a scale Standard Error 1.31	-6.2 units on a scale Standard Error 0.59	-5.9 units on a scale Standard Error 0.53
Change From Baseline in PASI Score Over Time Week 8	-4.6 units on a scale Standard Error 2.07	-4.6 units on a scale Standard Error 0.65	-4.6 units on a scale Standard Error 0.61
Change From Baseline in PASI Score Over Time Week 24	-3.1 units on a scale Standard Error 3.17	-6.3 units on a scale Standard Error 0.68	-5.9 units on a scale Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percent Change From Baseline in PASI Score Week 16	-45.6 percent change Standard Error 15.15	-59.2 percent change Standard Error 5.06	-57.3 percent change Standard Error 4.74
Percent Change From Baseline in PASI Score Week 24	-17.4 percent change Standard Error 45.65	-63.7 percent change Standard Error 5.78	-58.1 percent change Standard Error 8.01
Percent Change From Baseline in PASI Score Week 8	-51.6 percent change Standard Error 16.23	-43.7 percent change Standard Error 6.11	-44.8 percent change Standard Error 5.64

SECONDARY outcome

Timeframe: Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories: * 0 (Cleared): No evidence of scaling, erythema, or plaque elevation; * 1 (Minimal): Occasional fine scale over \<5% of lesions, faint erythema, minimal plaque elevation; * 2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation; * 3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation; * 4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation; * 5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation. The percentage of participants achieving a score of clear (0) or minimal (1) is reported.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time Week 8	16.7 percentage of participants Interval 0.0 to 46.5	27.5 percentage of participants Interval 13.7 to 41.3	26.1 percentage of participants Interval 13.4 to 38.8
Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time Week 16	16.7 percentage of participants Interval 0.0 to 46.5	35.0 percentage of participants Interval 20.2 to 49.8	32.6 percentage of participants Interval 19.1 to 46.2
Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	47.5 percentage of participants Interval 32.0 to 63.0	43.5 percentage of participants Interval 29.2 to 57.8

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area. A decrease in BSA affected by psoriasis indicates improvement.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 8	-3.5 percentage of body surface area Standard Error 2.95	-4.5 percentage of body surface area Standard Error 1.06	-4.4 percentage of body surface area Standard Error 0.98
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 16	-4.5 percentage of body surface area Standard Error 2.40	-6.4 percentage of body surface area Standard Error 1.08	-6.2 percentage of body surface area Standard Error 0.99
Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 24	-4.1 percentage of body surface area Standard Error 1.57	-6.3 percentage of body surface area Standard Error 0.89	-6.0 percentage of body surface area Standard Error 0.79

SECONDARY outcome

Timeframe: Baseline and weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 8	-33.9 percent change Standard Error 23.10	-34.1 percent change Standard Error 7.48	-33.4 percent change Standard Error 7.17
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 16	-34.1 percent change Standard Error 22.25	-54.2 percent change Standard Error 5.89	-51.4 percent change Standard Error 5.89
Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis Week 24	-32.7 percent change Standard Error 22.25	-61.7 percent change Standard Error 6.33	-57.8 percent change Standard Error 6.21

SECONDARY outcome

Timeframe: Baseline, weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 8	-5.0 units on a scale Standard Error 1.40	-4.8 units on a scale Standard Error 0.71	-4.8 units on a scale Standard Error 0.64
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 16	-3.8 units on a scale Standard Error 2.54	-5.9 units on a scale Standard Error 0.78	-5.6 units on a scale Standard Error 0.76
Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 24	-1.7 units on a scale Standard Error 4.29	-6.3 units on a scale Standard Error 0.69	-5.4 units on a scale Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline, weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 8	-43.0 percent change Standard Error 21.50	-38.6 percent change Standard Error 7.01	-39.2 percent change Standard Error 6.48
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 16	-22.9 percent change Standard Error 40.40	-38.9 percent change Standard Error 12.79	-36.7 percent change Standard Error 11.85
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time Week 24	14.4 percent change Standard Error 71.98	-55.0 percent change Standard Error 6.90	-44.5 percent change Standard Error 11.11

SECONDARY outcome

Timeframe: Baseline and Weeks 8, 16, and 24

Population: Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=40 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=46 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time Week 8	16.7 percentage of participants Interval 0.0 to 46.5	20.0 percentage of participants Interval 7.6 to 32.4	19.6 percentage of participants Interval 8.1 to 31.0
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time Week 16	16.7 percentage of participants Interval 0.0 to 46.5	40.0 percentage of participants Interval 24.8 to 55.2	37.0 percentage of participants Interval 23.0 to 50.9
Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time Week 24	16.7 percentage of participants Interval 0.0 to 46.5	40.0 percentage of participants Interval 24.8 to 55.2	37.0 percentage of participants Interval 23.0 to 50.9

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.

Outcome measures

Outcome measures
Measure	Primary Sub-optimal Responders - ADA + MTX n=6 Participants Participants who did not respond optimally to ADA monotherapy at least 16 weeks after initiating treatment (primary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Secondary Sub-optimal Responders - ADA + MTX n=39 Participants Participants who after an initial positive response to ADA monotherapy failed to maintain an optimal level of response (secondary sub-optimal responders) received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.	Adalimumab + Methotrexate n=45 Participants Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24	-2.6 mg/L Standard Error 0.47	0.1 mg/L Standard Error 1.52	-0.3 mg/L Standard Error 1.32

Adverse Events

Adalimumab + Methotrexate

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adalimumab + Methotrexate n=46 participants at risk Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Cardiac disorders Cardiac arrest	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Nervous system disorders Generalised tonic-clonic seizure	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Nervous system disorders Loss of consciousness	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Respiratory, thoracic and mediastinal disorders Hypercapnia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).

Other adverse events

Other adverse events
Measure	Adalimumab + Methotrexate n=46 participants at risk Participants received 40 mg adalimumab every other week and methotrexate, between 7.5 and 25 mg/week at the discretion of the Investigator, for 24 weeks.
Eye disorders Vision blurred	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Gastrointestinal disorders Abdominal discomfort	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Gastrointestinal disorders Abdominal distension	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Gastrointestinal disorders Nausea	6.5% 3/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
General disorders Chest pain	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
General disorders Cyst	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
General disorders Fatigue	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
General disorders Vessel puncture site bruise	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Beta haemolytic streptococcal infection	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Bronchitis	6.5% 3/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Folliculitis	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Gastroenteritis	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Nasopharyngitis	15.2% 7/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Pharyngitis streptococcal	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Pneumonia	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Sinusitis	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Streptococcal bacteraemia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Tooth abscess	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Tooth infection	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Upper respiratory tract infection	10.9% 5/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Infections and infestations Urinary tract infection	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Injury, poisoning and procedural complications Lower limb fracture	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Injury, poisoning and procedural complications Seroma	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Injury, poisoning and procedural complications Wrist fracture	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Investigations Alanine aminotransferase increased	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Investigations Aspartate aminotransferase increased	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Investigations Liver function test increased	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Metabolism and nutrition disorders Gout	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Metabolism and nutrition disorders Hyperlipidaemia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Musculoskeletal and connective tissue disorders Pain in extremity	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Metabolism and nutrition disorders Polymyalgia rheumatica	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Nervous system disorders Neuralgia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Nervous system disorders Paraesthesia	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Psychiatric disorders Insomnia	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Psychiatric disorders Mood altered	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Psychiatric disorders Sleep disorder	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Renal and urinary disorders Crystalluria	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Reproductive system and breast disorders Vulvovaginal dryness	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Skin and subcutaneous tissue disorders Acne	4.3% 2/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Vascular disorders Hypotension	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Vascular disorders Peripheral venous disease	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).
Nervous system disorders Dizziness	2.2% 1/46 • From the date of either the first dose of study adalimumab or the first dose of methotrexate up to 70 days after the last adalimumab injection during the study. The median duration of exposure to adalimumab was 168 days (range: 14 - 171 days).

Additional Information

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