Phase 3
N=193
A Study of Re-Treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00502840 ↗Enrolled (actual)
193
Serious AEs
24.3%
Results posted
Sep 2014
Primary outcome: Primary: Change From Baseline in DAS28 Score at Week 24 — -2.12 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rituximab [MabThera/Rituxan] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in DAS28 Score at Week 24 |
-2.12 | — |
| SECONDARY DAS28 Score by Treatment Course and Follow-up (FU) Visit |
5.15; 4.09; 3.72; 3.78; 3.94; 3.79 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' by Treatment Course |
78.0; 86.9; 86.8 | — |
| SECONDARY Percentage of Participants Achieving a Response By EULAR Category and Treatment Course |
32.4; 45.7; 43.0; 43.9; 44.7; 42.1 | — |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Score by Treatment Course |
1.43; 1.36; 1.31; 1.28; 1.33; 1.29 | — |
| SECONDARY Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score by Treatment Course |
20.16; 18.48; 18.81; 17.75; 18.17; 20.77 | — |
| SECONDARY Short-Form 36 (SF-36) Physical Composite Scores (PCS) by Treatment Course |
34.57; 36.28; 37.23; 37.94; 37.28; 36.92 | — |
| SECONDARY SF-36 MCS by Treatment Course |
44.04; 45.32; 45.06; 45.18; 44.35; 41.95 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Physical Functioning |
43.26; 46.80; 46.85; 49.58; 47.30; 46.92 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Bodily Pain |
37.22; 46.06; 47.98; 48.70; 46.55; 44.10 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Physical Role Functioning |
45.85; 50.04; 51.28; 52.92; 49.51; 47.44 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Emotional Role Functioning |
57.80; 61.91; 60.44; 62.12; 56.52; 55.98 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Emotional Well-Being |
61.71; 64.38; 64.70; 64.26; 64.08; 57.85 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Social Functioning |
66.47; 69.01; 68.75; 69.62; 67.50; 66.67 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - Vitality |
46.33; 49.51; 50.22; 50.57; 50.82; 45.99 | — |
| SECONDARY SF-36 Domain Scores by Treatment Course - General Heath Perceptions |
45.74; 47.46; 50.82; 50.65; 49.38; 46.15 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50%, or 70% Improvement (ACR20/ACR50/ACR70) by Treatment Course |
38.7; 19.1; 5.2; 51.4; 26.2; 5.6 | — |
| SECONDARY Swollen Joint Count |
8.52; 4.09; 3.65; 3.51 | — |
| SECONDARY Tender Joint Count |
12.92; 7.32; 6.31; 7.00 | — |
| SECONDARY Physician's Global Assessment of Disease Activity |
64.17; 28.50; 27.67; 28.82 | — |
| SECONDARY Patient's Global Assessment of Disease Activity |
63.40; 34.13; 34.50; 33.66 | — |
| SECONDARY Patient's Assessment of Pain |
61.90; 35.02; 35.12; 34.82 | — |
| SECONDARY C-Reactive Protein |
1.82; 0.89; 0.88; 0.84 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
31.30; 19.87; 19.45; 18.74 | — |
| SECONDARY Rheumatoid Factor (RF) |
187.18; 70.16; 63.17; 58.52 | — |
Summary
This single arm study will evaluate the efficacy and safety of repeated courses of MabThera in patients with active rheumatoid arthritis who have participated in ML19070, and have completed the week 24 visit. Eligible patients (DAS28 >2.6 after week 24), will receive 2 infusions of 1g MabThera (Day 1 and day 15). For all patients in this extension study, up to 3 repeated courses of treatment are allowed. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients with rheumatoid arthritis who participated in ML19070, and have completed the week 24 visit;
- eligible for re-treatment (DAS28 >2.6 after week 24, swollen joint count >=4, tender joint count >=4).
Exclusion Criteria
- patients who have withdrawn from treatment in ML19070 pre-week 16;
- patients with a previous response in DAS28 <0.6 to MabThera after week 16;
- concurrent treatment with any DMARD except for methotrexate, any TNF alpha inhibitor, or other biologic or investigational agent.
Data sourced from ClinicalTrials.gov (NCT00502840). 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.