Phase 3
Completed N=799
Efficacy and Safety of Adalimumab and Methotrexate (MTX) Versus MTX Monotherapy in Subjects With Early Rheumatoid Arthritis
Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00195663 ↗
Enrolled (actual)
799
Serious AEs
32.6%
Results posted
Feb 2010
Primary outcomePrimary: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 — 118; 113; 165 participants — p=<0.001
Summary
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 |
118; 113; 165 | <0.001 sig |
| PRIMARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 |
5.7; 3.0; 1.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52 |
-0.8; -0.8; -1.1 | <0.001 sig |
| SECONDARY Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 104 |
110; 101; 158 | < 0.001 sig |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) at Week 104 |
10.4; 5.5; 1.9 | < 0.001 sig |
| SECONDARY Number of Participants Who Achieved Clinical Remission, Defined as a Disease Activity 28 (DAS28) Score < 2.6 at Week 52 |
53; 64; 115 | < 0.001 sig |
| SECONDARY Change From Baseline in the Physical Component of the Short Form-36 Health Status Survey (SF-36) at Week 52 |
12.5; 12.6; 16.7 | < 0.001 sig |
| SECONDARY Number of Participants With Major Clinical Response After 104 Weeks of Treatment |
70; 67; 130 | < 0.001 sig |
| SECONDARY Change From Baseline in the Mental Component of the Short Form-36 Health Status Survey (SF-36) at Week 52 |
6.5; 7.1; 7.2 | 0.5402 |
| SECONDARY Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Weeks 26 and 76 |
104; 96; 157; 114; 114; 161 | — |
| SECONDARY Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria During the Double-blind Phase |
158; 146; 184; 161; 149; 195 | — |
| SECONDARY Number of Participants Meeting American College of Rheumatology 70% (ACR70) Response Criteria During the Double-blind Phase |
57; 54; 114; 70; 71; 122 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) During the Double-blind Treatment Phase |
-0.6; -0.6; -0.8; -0.8; -0.8; -0.9 | — |
| SECONDARY Number of Participants With Improvement in the HAQ-DI Score ≥ 0.3 During the Double-blind Treatment Phase |
172; 169; 200; 158; 151; 186 | — |
| SECONDARY Change From Baseline in Health Utilities Index Mark 2 and Mark 3 (HUI 2/3) During the Double-blind Treatment Phase |
0.2; 0.2; 0.2; 0.2; 0.2; 0.2 | — |
| SECONDARY Change From Baseline in the Short Form-36 Health Status Survey (SF-36) During the Double-blind Treatment Phase |
11.2; 10.8; 14.7; 12.4; 13.4; 16.8 | — |
| SECONDARY Numeric American College of Rheumatology (ACR-N) During the Double-blind Treatment Phase |
44.7; 39.1; 57.0; 50.2; 44.4; 66.3 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28) During the Double-blind Treatment Phase |
-2.6; -2.4; -3.2; -2.8; -2.8; -3.6 | — |
| SECONDARY Change From Baseline in Joint Erosion Score During the Double-blind Treatment Period |
3.7; 1.7; 0.8; 6.4; 3.0; 1.0 | — |
| SECONDARY Change From Baseline in Joint Space Narrowing Score During the Double-blind Treatment Period |
2.0; 1.3; 0.5; 4.0; 2.6; 0.9 | — |
| SECONDARY Number of Participants With No Worsening in Modified Total Sharp Score or Components During the Double-blind Treatment Phase |
78; 112; 141; 70; 105; 136 | — |
| SECONDARY Number of Participants With No Erosions at Baseline and No New Erosions at Weeks 52 and 104 |
8; 10; 13; 7; 8; 11 | — |
| SECONDARY Number of Participants With Non-Involved Joints at Baseline and No Newly Involved Joints at Weeks 52 and 104 |
4; 9; 12; 3; 7; 9 | — |
| SECONDARY Number of Participants Meeting ACR20 Response Criteria Over 10 Years by Adalimumab Exposure |
340; 332; 231; 154 | — |
| SECONDARY Number of Participants Meeting ACR50 Response Criteria Over 10 Years by Adalimumab Exposure |
269; 266; 194; 127 | — |
| SECONDARY Number of Participants Meeting ACR70 Response Criteria Over 10 Years by Adalimumab Exposure |
186; 207; 153; 102 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Over 10 Years by Adalimumab Exposure |
-0.9; -0.9; -0.7; -0.9 | — |
| SECONDARY Change From Baseline in DAS28 Over 10 Years by Adalimumab Exposure |
-3.2; -3.3; -2.8; -3.9 | — |
| SECONDARY Number of Participants With DAS28 < 2.6 and < 3.2 Over 10 Years by Adalimumab Exposure |
173; 244; 215; 271; 190; 244 | — |
| SECONDARY Change From Baseline in Modified Total Sharp Score (mTSS) Over 10 Years |
6.3; 5.1; 0.3; 10.8; 9.2; 3.9 | — |
| SECONDARY Number of Participants With No Radiographic Progression Over 10 Years |
36; 40; 65; 26; 22; 33 | — |
| SECONDARY Composite Score of ACR50 Plus No Change in Modified Total Sharp Score |
— | — |
| SECONDARY Number of Participants With a Major Clinical Response Over 10 Years by Adalimumab Exposure |
273 | — |
| SECONDARY Number of Participants With Improvement in HAQ-DI by 0.22 and 0.5 Units Over 10 Years by Adalimumab Exposure |
353; 285; 324; 265; 239; 188 | — |
Eligibility Criteria
Inclusion Criteria
- Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Diagnosis of rheumatoid arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR) criteria, with a disease duration less than 3 years, at least 8 swollen joints out of the 66 joints assessed, at least 10 tender joints out of the 68 joints assessed, at least 1 joint erosion or rheumatoid factor (RF) positivity, erythrocyte sedimentation rate (ESR) >= 28 mm/1h or C-reactive protein (CRP) >= 1.5 mg/dl
Exclusion Criteria
- Chronic arthritis diagnosed before the age of 16
- Preceding treatment with MTX, cyclophosphamide, cyclosporin, azathioprine or more than 2 other disease-modifying anti-rheumatic drugs (DMARDs)
- Subject previously received anti-tumor necrosis factor (TNF) therapy
- Permanently wheelchair-bound or bedridden patients
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Data sourced from ClinicalTrials.gov (NCT00195663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.