Trial Outcomes & Findings for Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA) (NCT NCT01185301)
NCT ID: NCT01185301
Last Updated: 2013-11-15
Results Overview
Percentage of participants achieving low disease activity as defined by a clinical response (DAS28\[CRP\] \< 3.2). 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 are 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
395 participants
Primary outcome timeframe
Week 26
Results posted on
2013-11-15
Participant Flow
Participant milestones
| Measure |
ADA + 2.5 mg MTX
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
99
|
98
|
|
Overall Study
COMPLETED
|
83
|
93
|
93
|
89
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
6
|
9
|
Reasons for withdrawal
| Measure |
ADA + 2.5 mg MTX
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
1
|
|
Overall Study
Other Reason
|
3
|
2
|
2
|
2
|
Baseline Characteristics
Study to Determine the Effects of Different Doses of Methotrexate (MTX) When Taken With Adalimumab in Subjects With Early Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
52.0 years
STANDARD_DEVIATION 13.19 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 13.14 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 14.41 • n=4 Participants
|
51.9 years
STANDARD_DEVIATION 13.46 • n=21 Participants
|
|
Age, Customized
< 65 years
|
84 participants
n=5 Participants
|
89 participants
n=7 Participants
|
85 participants
n=5 Participants
|
77 participants
n=4 Participants
|
335 participants
n=21 Participants
|
|
Age, Customized
> 65 years
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
21 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP])
|
6.10 scores on a scale
STANDARD_DEVIATION 0.921 • n=5 Participants
|
6.22 scores on a scale
STANDARD_DEVIATION 0.943 • n=7 Participants
|
5.86 scores on a scale
STANDARD_DEVIATION 0.971 • n=5 Participants
|
5.91 scores on a scale
STANDARD_DEVIATION 1.014 • n=4 Participants
|
6.02 scores on a scale
STANDARD_DEVIATION 0.970 • n=21 Participants
|
|
Modified Total Sharp Score (mTSS)
|
9.79 score
STANDARD_DEVIATION 12.849 • n=5 Participants
|
8.60 score
STANDARD_DEVIATION 8.912 • n=7 Participants
|
10.76 score
STANDARD_DEVIATION 13.017 • n=5 Participants
|
10.55 score
STANDARD_DEVIATION 12.852 • n=4 Participants
|
9.92 score
STANDARD_DEVIATION 12.005 • n=21 Participants
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
1.49 units on a scale
STANDARD_DEVIATION 0.737 • n=5 Participants
|
1.57 units on a scale
STANDARD_DEVIATION 0.624 • n=7 Participants
|
1.62 units on a scale
STANDARD_DEVIATION 0.667 • n=5 Participants
|
1.58 units on a scale
STANDARD_DEVIATION 0.653 • n=4 Participants
|
1.57 units on a scale
STANDARD_DEVIATION 0.670 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Percentage of participants achieving low disease activity as defined by a clinical response (DAS28\[CRP\] \< 3.2). 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 are 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 |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) Low Disease Activity at Week 26
|
42.9 percentage of participants
|
44.0 percentage of participants
|
56.6 percentage of participants
|
60.2 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Disease remission was defined as a disease activity score, based on CRP, for 28 joints that was \< 2.6 (DAS28\[CRP\] \< 2.6). 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 are included in the DAS28 score. Scores on the DAS28 range from 0 to 10.
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With DAS28(CRP) Remission at Week 26
|
27.6 percentage of participants
|
32.0 percentage of participants
|
37.4 percentage of participants
|
44.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Response, as defined by ACR 20 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are 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: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * Acute phase reactant value (C-reactive protein).
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 20 Criteria Response at Week 26
|
67.3 percentage of participants
|
74.0 percentage of participants
|
76.8 percentage of participants
|
79.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Response, as defined by ACR 50 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are 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: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * Acute phase reactant value (C-reactive protein).
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 50 Criteria Response at Week 26
|
45.9 percentage of participants
|
51.0 percentage of participants
|
53.5 percentage of participants
|
62.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Response, as defined by ACR 70 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are 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: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * Acute phase reactant value (C-reactive protein).
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 70 Criteria Response at Week 26
|
24.5 percentage of participants
|
34.0 percentage of participants
|
41.4 percentage of participants
|
45.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Response, as defined by ACR 90 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 90% improvement in tender joint count; ≥ 90% improvement in swollen joint count; and ≥ 90% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * Acute phase reactant value (C-reactive protein).
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 90 Criteria Response at Week 26
|
7.1 percentage of participants
|
10.0 percentage of participants
|
17.2 percentage of participants
|
16.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
Response, as defined by ACR 100 criteria at Week 26. A participant is a responder if the following 3 criteria for improvement from Baseline are met: ≥ 100% improvement in tender joint count; ≥ 100% improvement in swollen joint count; and ≥ 100% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment Questionnaire * Acute phase reactant value (C-reactive protein).
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR) 100 Criteria Response at Week 26
|
1.0 percentage of participants
|
1.0 percentage of participants
|
2.0 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population with non-missing baseline and at least 1 non-missing post-baseline value (baseline is defined as the last non-missing value prior to the first dose of study drug); last observation carried forward.
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 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 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=96 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=98 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=96 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 26
|
-0.72 units on a scale
Standard Deviation 0.664
|
-0.71 units on a scale
Standard Deviation 0.717
|
-0.78 units on a scale
Standard Deviation 0.647
|
-0.82 units on a scale
Standard Deviation 0.698
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
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. The minimal clinically important difference (MCID) defined for the HAQ-DI is a change from Baseline of ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. Negative change from Baseline in the overall score indicates improvement.
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ -0.22 at Week 26
|
68.4 percentage of participants
|
70.0 percentage of participants
|
73.7 percentage of participants
|
77.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population with available data at time point (observed cases).
The modified Total Sharp Score (mTSS) is a measure of change in joint health from digitized images of radiographs of hands and feet. 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 |
ADA + 2.5 mg MTX
n=88 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=94 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=95 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=90 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26
|
0.9 score on a scale
Standard Deviation 5.62
|
0.3 score on a scale
Standard Deviation 1.92
|
0.4 score on a scale
Standard Deviation 3.17
|
0.2 score on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
"No radiographic progression" was defined as a change from Baseline in modified Total Sharp Score (mTSS) at Week 26 of ≤ 0.5. mTSS is a measure of change in joint health from digitized images of radiographs of hands and feet. 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 |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With No Radiographic Progression at Week 26
|
64.3 percentage of participants
|
72.0 percentage of participants
|
76.8 percentage of participants
|
77.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
SDAI is a measure of disease activity derived as follows: SDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) + CRP (mg/dL), where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 \[none\] to 10 \[severe\]), and CRP is C-reactive protein measured in mg/dL. SDAI total score = 0 to 86. SDAI ≤ 3.3 indicates disease remission, \> 3.4 to 11 = low disease activity, \> 11 to 26 = moderate disease activity, and \> 26 = high disease activity.
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 26
|
11.2 percentage of participants
|
22.0 percentage of participants
|
28.3 percentage of participants
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Population: Intent-to-Treat population; participants with a missing response were imputed as non-responders.
CDAI is a measure of disease activity derived as follows: CDAI = SJC28 + TJC28 + GH (cm) + PhGA (cm) where TJC28 and SJC28 represent total tender joint count and total swollen joint count, respectively, based on 28 joints (including the left and right side of the body), GH = Patient's Global Assessment of Disease Activity, and PhGA = Physician's Global Assessment of Disease Activity (both measured on a visual analogue scale with a range of 0 \[none\] to 10 \[severe\]). CDAI total score = 0 to 76. CDAI ≤ 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \> 10 to 22 = moderate disease activity, and \> 22 = high disease activity.
Outcome measures
| Measure |
ADA + 2.5 mg MTX
n=98 Participants
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 Participants
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 Participants
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 Participants
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 26
|
12.2 percentage of participants
|
22.0 percentage of participants
|
29.3 percentage of participants
|
27.6 percentage of participants
|
Adverse Events
ADA + 2.5 mg MTX
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
ADA + 5 mg MTX
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
ADA + 10 mg MTX
Serious events: 3 serious events
Other events: 34 other events
Deaths: 0 deaths
ADA + 20 mg MTX
Serious events: 7 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADA + 2.5 mg MTX
n=98 participants at risk
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 participants at risk
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 participants at risk
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 participants at risk
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
General disorders
ASTHENIA
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
General disorders
CHEST PAIN
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Infections and infestations
SEPSIS
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
3.1%
3/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
Other adverse events
| Measure |
ADA + 2.5 mg MTX
n=98 participants at risk
2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
|
ADA + 5 mg MTX
n=100 participants at risk
5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 10 mg MTX
n=99 participants at risk
10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
|
ADA + 20 mg MTX
n=98 participants at risk
MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
1.0%
1/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.1%
5/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.0%
5/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
4.0%
4/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.1%
3/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.0%
6/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.1%
6/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
3.1%
3/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Gastrointestinal disorders
NAUSEA
|
7.1%
7/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.0%
5/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
13.1%
13/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
8.2%
8/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
General disorders
FATIGUE
|
2.0%
2/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
2.0%
2/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.1%
6/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.1%
3/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.0%
6/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.1%
6/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
11.2%
11/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.0%
2/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
2.0%
2/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
3.0%
3/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.1%
5/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.1%
6/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
2.0%
2/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
3.0%
3/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Nervous system disorders
DIZZINESS
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
0.00%
0/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.1%
6/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Nervous system disorders
HEADACHE
|
4.1%
4/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.0%
6/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.1%
5/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
9.2%
9/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
1.0%
1/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
5.0%
5/100 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
6.1%
6/99 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
8.2%
8/98 • Treatment-emergent adverse events and serious adverse events, defined as those that began after the first dose of study drug, but within 70 days after the last dose of study drug. Duration of treatment was 24 weeks for ADA and 25 weeks for MTX.
|
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