Phase 4
Completed N=1,032
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00420927 ↗Enrolled (actual)
1,032
Serious AEs
7.7%
Results posted
Sep 2011
Primary outcomePrimary: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 — 59; 73; 94; 61 Participants — p=0.023
Summary
This study compared the safety and efficacy of combination therapy with adalimumab plus methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 |
59; 73; 94; 61; 129 | 0.023 sig |
| SECONDARY Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 1 |
59; 73; 94; 61; 129 | 0.082 |
| SECONDARY Number of Subjects With DAS28 Low Disease Activity (DAS28 Less Than 3.2) at Week 78 |
71; 80; 108; 78; 185 | 0.280 |
| SECONDARY Number of Subjects With DAS28 Remission (DAS28 Less Than 2.6) at Week 78 |
57; 77; 71; 66; 138 | 0.026 sig |
| SECONDARY Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS Less Than or Equal to 0.5) at Week 78 |
70; 84; 182; 77; 220 | 0.060 |
| SECONDARY Number of Subjects Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 78 |
84; 89; 172; 90; 257 | 0.395 |
| SECONDARY Number of Subjects Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 78 |
72; 82; 120; 78; 198 | 0.159 |
| SECONDARY Number of Subjects Meeting American College of Rheumatology 70% (ACR70) Response Criteria at Week 78 |
57; 73; 78; 64; 137 | 0.060 |
| SECONDARY Change From Baseline in DAS28 Score at Week 78 |
-3.54; -3.71; -2.70; -3.04; -3.07 | 0.004 sig |
| SECONDARY Number of Subjects With Clinical Disease Activity Index (CDAI) Low Disease Activity (CDAI Less Than or Equal to 10) at Week 78 |
75; 84; 109; 82; 195 | 0.240 |
| SECONDARY Number of Subjects With Simplified Disease Activity Index (SDAI) Low Disease Activity (SDAI Less Than or Equal to 11) at Week 78 |
73; 79; 106; 76; 192 | 0.230 |
| SECONDARY Number of Subjects With Clinical Disease Activity Index (CDAI) Remission (CDAI Less Than or Equal to 2.8) at Week 78 |
47; 58; 39; 54; 94 | 0.301 |
| SECONDARY Number of Subjects With Simplified Disease Activity Index (SDAI) Remission (SDAI Less Than or Equal to 3.3) at Week 78 |
45; 55; 39; 51; 92 | 0.314 |
| SECONDARY Change From Baseline in CDAI Score at Week 78 |
-33.30; -33.29; -29.06; -27.63; -31.30 | 0.030 sig |
| SECONDARY Change From Baseline in SDAI Score at Week 78 |
-35.61; -35.16; -31.00; -29.30; -33.43 | 0.036 sig |
| SECONDARY Change From Baseline in Synovitis Score According to the Rheumatoid Arthritis Magnetic Resonance Imaging (RA MRI) Scoring System (RAMRIS) at Week 78 |
2.00; -3.38; -3.25; -3.88; -4.27 | 0.037 sig |
| SECONDARY Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5) and Normal Function (HAQ-DI Less Than 0.5) at Week 78 |
49; 59; 65; 53; 84 | 0.192 |
| SECONDARY Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than or Equal to 0.5), and ACR70 Response at Week 78 |
37; 56; 40; 43; 67 | 0.028 sig |
| SECONDARY Number of Subjects With No Radiographic Progression (Change From Baseline in mTSS of Less Than or Equal to 0.5), Normal Function (HAQ-DI Less Than 0.5), and DAS28 Remission (DAS28 Less Than 2.6) at Week 78 |
39; 53; 38; 43; 63 | 0.074 |
Eligibility Criteria
Inclusion Criteria
- Subject must be 18 or older and in good health
- Subject must meet the definition of early rheumatoid arthritis (RA) defined by the 1987-revised American College of Rheumatology (ACR) classification criteria and had disease duration of less than 1 year from diagnosis
- Subject must have a Disease Activity Score (DAS28, based on C-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
- Subject must fulfill at least one of the following three criteria:
- Rheumatoid factor positive
- Greater than 1 joint erosion
- Anti-cyclic citrullinated peptide (CCP) antibody positive.
Exclusion Criteria
- Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy
- Subject has received any biologic or investigational therapy within 6 weeks prior to Baseline
- Subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
Data sourced from ClinicalTrials.gov (NCT00420927). 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.