Phase 3
Completed N=755
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00299104 ↗Enrolled (actual)
755
Serious AEs
18.6%
Results posted
Aug 2011
Primary outcomePrimary: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 — 1.079; 0.646; 0.359 Score on a scale — p=0.0016
Summary
This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 |
1.079; 0.646; 0.359 | 0.0016 sig |
| SECONDARY Change From Baseline in Modified Sharp Erosion Score at Week 52 |
0.738; 0.453; 0.233 | 0.0004 sig |
| SECONDARY Percentage of Patients Without Radiographic Progression at Week 52 |
53.4; 57.7; 63.5 | 0.3803 |
| SECONDARY Percentage of Patients Without Radiographic Progression in Total Erosion Score at Week 52 |
54.7; 59.0; 66.8 | 0.3752 |
| SECONDARY Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 52 |
0.341; 0.193; 0.126 | 0.5939 |
| SECONDARY Change From Baseline in the Modified Total Sharp Score at Week 24 |
0.701; 0.508; 0.328 | — |
| SECONDARY Change From Baseline in the Total Erosion Score at Week 24 |
0.491; 0.404; 0.220 | — |
| SECONDARY Change From Baseline in Modified Joint Space Narrowing (JSN) Score at Week 24 |
0.210; 0.176; 0.108 | — |
| SECONDARY Percentage of Participants Without Radiographic Progression at Week 24 |
59.7; 65.3; 71.7 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) ACR50 Response at Week 52 |
41.8; 59.4; 64.8 | <0.0001 sig |
| SECONDARY Change From Baseline in the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 52 |
-2.33; -3.35; -3.46 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) ACR70 Response at Week 52 |
24.9; 42.2; 46.8 | — |
| SECONDARY Percentage of Participants With DAS28-ESR Remission at Week 52 |
12.6; 25.4; 30.5 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Good Response at Week 52 |
18.1; 39.0; 41.6 | — |
| SECONDARY The Percentage of Participants With Major Clinical Response at Week 52 |
8.4; 18.1; 21.2 | — |
| SECONDARY Percentage of Participants With DAS28-ESR Low Disease Activity at Week 52 |
19.8; 40.3; 43.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) ACR20 Response at Week 52 |
64.3; 76.7; 80.0 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) ACR90 Response at Week 52 |
9.2; 17.3; 16.4 | — |
| SECONDARY Change in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score From Baseline at Week 52 |
10.154; 11.833; 12.426 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 |
-0.800; -1.038; -1.023 | <0.0001 sig |
| SECONDARY Change From Baseline in the SF-36 Physical Health Component Summary Score at Week 52 and Week 104 |
8.953; 11.022; 12.205; 8.617; 11.032; 12.649 | — |
| SECONDARY Change From Baseline in the SF-36 Mental Health Component Summary Score at Week 52 and Week 104 |
6.689; 7.718; 8.167; 6.295; 7.617; 9.066 | — |
| SECONDARY Percentage of Participants With Categorical Change in Health Assessment Questionnaire- Disability Index (HAQ-DI) From Baseline at Week 52 |
77.1; 86.7; 86.8; 14.1; 8.8; 8.0 | — |
| SECONDARY Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Physical Health Component Score at Week 52 |
63.2; 69.9; 76.4 | — |
| SECONDARY Percentage of Patients With Minimally Clinically Important Difference (MCID) in the SF-36 Mental Health Component Score at Week 52 |
49.0; 50.8; 57.0 | — |
| SECONDARY Change From Baseline in the Modified Total Sharp Score at Week 104 |
1.948; 0.761; 0.406 | <0.0001 sig |
| SECONDARY Change From Baseline in the Total Erosion Score at Week 104 |
1.315; 0.499; 0.227 | — |
| SECONDARY Percentage of Participants Without Radiographic Progression at Week 104 |
37.3; 49.4; 56.6 | — |
| SECONDARY Percentage of Participants Without Radiographic Progression in the Total Erosion Score at Week 104 |
38.2; 52.7; 58.6 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 104 |
-0.806; -1038; -1.055 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Adult patients 18-80 years of age
- RA for ≥ 2 months;
- Receiving outpatient treatment
- Patients naive to, and considered to be candidates for, methotrexate treatment
Exclusion criteria
- Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- Inflammatory joint disease other than RA, or other systemic autoimmune disorder
- Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16
- Surgery within 12 weeks of study
- Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy
- Concurrent treatment with any biologic agent or DMARD other than methotrexate
Data sourced from ClinicalTrials.gov (NCT00299104). 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.