Phase 4
Completed N=40
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Source: ClinicalTrials.gov NCT00462345 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24 — 47.5 percentage of participants
Summary
This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24 |
47.5 | — |
| SECONDARY Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24 |
7.5 | — |
| SECONDARY Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24 |
5.0 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS-28) |
6.76; 5.31; -1.45 | — |
| SECONDARY Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2 |
60.0 | — |
| SECONDARY Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24 |
5.0; 65.0; 30.0 | — |
| SECONDARY Swollen Join Count (SJC) |
16.3; -8.9; -11.6 | — |
| SECONDARY Tender Joint Count (TJC) |
21.9; -9.0; -13.9 | — |
| SECONDARY Patient Global Assessment of Disease Activity (VAS) |
72.6; -20.5; -31.8 | — |
| SECONDARY Physician Global Assessment of Disease Activity (VAS) |
72.8; -30.4; -42.1 | — |
| SECONDARY Patient Assessment of Pain (VAS) |
69.3; -16.8; -28.2 | — |
| SECONDARY C-reactive Protein (CRP) Level |
3.80; -1.54; -2.23 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
77.2; -23.4; -36.1 | — |
| SECONDARY HAQ-DI Score |
1.66; -0.34; -0.53 | — |
| SECONDARY Physical Function as Assessed by Short Form 36 (SF-36) |
27.7; 26.6; 29.2; 31.7; 35.8; 41.5 | — |
| SECONDARY SF-36 Mental Component Scores |
30.3; 41.7; 36.8; 52.9; 35.7; 55.5 | — |
| SECONDARY Modified Total Sharp-Genant Score (mTSS) |
79.5; 0.26; 0.64 | — |
| SECONDARY Modified Sharp Radiographic Erosion Score (ES) |
25.2; 0.18; 0.49 | — |
| SECONDARY Modified Sharp Radiographic Joint Space Narrowing Score (JSN) |
54.3; 0.08; 0.15 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, 18-80 years of age;
- rheumatoid arthritis for >=6 months;
- receiving outpatient treatment;
- an inadequate response to at least one anti-TNF therapy;
- stable methotrexate for >=12 weeks.
Exclusion Criteria
- other rheumatic autoimmune disease or inflammatory joint disease;
- previous treatment with MabThera;
- concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Data sourced from ClinicalTrials.gov (NCT00462345). 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.