Phase 3 N=185 Randomized Double-blind Treatment

A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00578305 ↗

Enrolled (actual)

185

Serious AEs

4.7%

Results posted

Apr 2015

Primary outcome: Primary: Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24 — 0.13; 0.39; 1.33 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rituximab (Biological); Placebo (Drug); Methylprednisolone (Drug); Methotrexate (Drug); Folic acid or folate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Week 24	0.13; 0.39; 1.33	—
SECONDARY Change in Magnetic Resonance Imaging (MRI) Erosion Score From Baseline to Weeks 12 and 52	0.42; 0.13; 0.33; 0.11; -0.30; 3.02	—
SECONDARY Change in Magnetic Resonance Imaging (MRI) Synovitis Score From Baseline to Weeks 12, 24, and Week 52	-0.50; -1.15; -0.22; -1.14; -1.81; 0.20	—
SECONDARY Change in Magnetic Resonance Imaging (MRI) Osteitis Score From Baseline to Weeks 12, 24, and Week 52	-2.11; -1.88; -0.14; -2.91; -2.86; 0.07	—
SECONDARY Percentage of Participants With no Newly Eroded Joints at Weeks 24 and 52	77.4; 73.3; 55.5; 77.4; 40; 60.3	—
SECONDARY Percentage of Participants With no Progression/no Worsening in Bone Erosion at Weeks 24 and 52	50.0; 51.7; 33.3; 88.7; 96.7; 81.0	—
SECONDARY Percentage of Participants With Improvement in Synovitis at Weeks 24 and 52	41.9; 56.7; 22.2; 41.9; 56.7; 22.2	—
SECONDARY Percentage of Participants With Improvement in Osteitis at Weeks 24 and 52	50.0; 51.7; 22.2; 50.0; 51.7; 22.2	—
SECONDARY Change From Baseline in the Disease Activity Score 28 (DAS28) at Weeks 24 and 52	-1.714; -1.683; -0.752; -2.055; -1.801; -0.747	—
SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 24 and 52	33.9; 22.0; 58.7; 37.1; 42.4; 22.2	—
SECONDARY Percentage of Participants With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Weeks 24 and 52	33.9; 36.7; 19.0; 37.1; 38.3; 9.5	—
SECONDARY Percentage of Participants in Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Weeks 24 and 52	21.0; 28.3; 12.7; 25.8; 25.0; 7.9	—
SECONDARY Percentage of Participants With an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Weeks 24 and 52	51.6; 51.7; 28.6; 24.2; 26.7; 11.1	—
SECONDARY Percentage of Participants Achieving a Major Clinical Response at Week 52	6.5; 6.7; 1.6	—
SECONDARY Correlation of Magnetic Resonance Imaging Assessments and Clinical Outcome Measures	0.341; 0.425; 0.446; 0.287; 0.234; 0.355	—
SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 24 and 52	-0.425; -0.439; -0.194; -0.520; -0.417; -0.177	—
SECONDARY Adverse Events (AEs), Laboratory Parameters, C-reactive Protein, ESR.	—	—

Summary

This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of progression of structural joint damage in participants with active rheumatoid arthritis who had an inadequate clinical response to methotrexate. Participants were randomized to receive rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15 every 24 weeks in the main study; all participants received concomitant methotrexate at a stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were provided to eligible participants. Structural joint damage was assessed by magnetic resonance imaging (MRI) at baseline and at intervals during the study.

Eligibility Criteria

Inclusion Criteria

Adult patients, 18-80 years of age.
Active rheumatoid arthritis for ≥ 3 months and ≤ 10 years.
Evidence of erosive disease and/or clinical synovitis in a signal joint.
Inadequate response to 12.5-25 mg/week methotrexate for ≥ 12 weeks.

Exclusion Criteria

Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis. - Any surgical procedure within 12 weeks prior to baseline.
Previous treatment with a biologic agent or with a B cell modulating or cell depleting therapy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00578305). 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.