Phase 3
Completed N=511
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00299130 ↗Enrolled (actual)
511
Serious AEs
19.2%
Results posted
Jun 2013
Primary outcomePrimary: Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 — 23.3; 54.5; 50.6 percentage of participants
Summary
This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 |
23.3; 54.5; 50.6 | — |
| SECONDARY Percentage of Participants With an ACR50 Response at Week 24 |
9.3; 26.3; 25.9 | — |
| SECONDARY Percentage of Participants With an ACR70 Response at Week 24 |
5.2; 9.0; 10.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24 |
-0.76; -1.71; -1.68 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24 |
66.3; 33.5; 37.1; 29.1; 49.1; 51.2 | — |
| SECONDARY Percent Change From Baseline in Swollen Joint Count |
-21.6; -47.4; -49.1; -38.9; -54.0; -59.3 | — |
| SECONDARY Percent Change From Baseline in Tender Joint Count |
-14.2; -42.5; -31.5; -37.1; -50.2; -45.1 | — |
| SECONDARY Percent Change From Baseline in Patient's Global Assessment of Disease Activity |
-14.0; -31.5; -29.1; -28.0; -39.7; -36.6 | — |
| SECONDARY Percent Change From Baseline in Patient's Pain Assessment |
-9.7; -25.7; -29.1; -24.4; -35.5; -36.3 | — |
| SECONDARY Percent Change From Baseline in Physician's Global Assessment of Disease Activity |
-25.3; -36.9; -35.4; -39.4; -40.5; -49.0 | — |
| SECONDARY Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
-14.7; -26.9; -23.4; -22.6; -30.2; -30.6 | — |
| SECONDARY Percent Change From Baseline in C-Reactive Protein |
58.1; -27.5; -23.1; 40.1; -37.3; -34.9 | — |
| SECONDARY Percent Change From Baseline in Erythrocyte Sedimentation Rate |
8.0; -28.0; -29.2; -14.5; -31.3; -36.7 | — |
| SECONDARY Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components) |
11.1; 23.7; 22.8; 21.3; 26.4; 27.4 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score |
2.078; 3.532; 3.866; 4.214; 4.165; 4.362 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score |
3.304; 6.931; 7.604; 8.449; 8.079; 8.964 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score |
3.553; 5.460; 5.653; 6.212; 6.778; 6.854 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score |
2.713; 5.618; 5.175; 6.423; 6.812; 6.497 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score |
3.278; 2.770; 4.486; 3.890; 4.583; 4.224 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score |
3.631; 4.230; 5.910; 6.853; 5.925; 5.869 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score |
2.529; 5.985; 6.468; 6.569; 7.112; 6.159 | — |
| SECONDARY Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score |
1.829; 4.634; 4.464; 4.724; 6.257; 4.446 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores |
2.661; 5.564; 6.398; 5.506; 6.269; 6.203 | — |
| SECONDARY Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24 |
4.7; 17.5; 12.4; 2.3; 9.6; 9.4 | — |
| SECONDARY Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24 |
47.7; 66.1; 58.2; 32.6; 23.6; 32.4 | — |
| SECONDARY Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48 |
54.7; 73.3; 68.8; 29.1; 17.0; 25.3 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48 |
41.3; 26.9; 31.8; 41.9; 53.3; 47.6 | — |
| SECONDARY Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48 |
18.1; 20.0; 24.3; 7.0; 9.1; 11.2 | — |
| SECONDARY Percentage of Participants With an ACR50 Response at Week 48 |
18.6; 32.9; 34.1 | — |
| SECONDARY Percentage of Participants With an ACR70 Response at Week 48 |
9.3; 12.6; 13.5 | — |
Eligibility Criteria
Inclusion criteria
- Adult patients 18-80 years of age.
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- Receiving outpatient treatment for RA.
- Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- At screening, either
- C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or
- Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour.
- Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
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 or planned within 24 weeks of randomization.
- Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
Data sourced from ClinicalTrials.gov (NCT00299130). 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.