Phase 4
Completed N=20
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.
Source: ClinicalTrials.gov NCT00424502 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Disease Activity Score Based on 28-Joint Count (DAS28) — 6.03; 4.01 units on a scale — p=<0.0001
Summary
This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). 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 Disease Activity Score Based on 28-Joint Count (DAS28) |
6.03; 4.01 | <0.0001 sig |
| SECONDARY Health Assessment Questionnaire - Disability Index (HAQ-DI) Scores |
1.14; 0.87 | <0.0001 sig |
| SECONDARY Anti-cyclic Citrullinated Peptide (Anti-CCP) |
731.07; 846.41 | — |
| SECONDARY Vascular Endothelial Growth Factor (VEGF) |
516.68; 520.15 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
45.25; 30.85 | 0.012 sig |
| SECONDARY C-Reactive Protein (CRP) |
6.13; 4.32 | 0.337 |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- diagnosed RA for >=3 months prior to first administration of study medication;
- inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
- if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.
Exclusion Criteria
- other chronic inflammatory diseases;
- use of parental corticosteroids within 4 weeks prior to screening;
- severe heart failure, or severe, uncontrolled cardiac disease.
Data sourced from ClinicalTrials.gov (NCT00424502). 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.