Trial information
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single anti-TNF Inhibitor.
Status: Recruiting
Protocol number: ML19070
Sponsor: Hoffmann-La Roche AG
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the safety of MabThera, and its effect on treatment response, in patients with rheumatoid arthritis following inadequate response to a single anti-TNF agent
Brief summary: This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals. Target sample size is 300.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. DAS 28 at week 24
Key secondary outcomes: 1. Efficacy: ACR20/50/70, HAQ, SF-36, FACIT-F, TJC, SJC, CRP, ESR, RF, Sharp score. Safety: AEs.
Inclusion criteria:
- adult patients, 18-75 years of age;
- rheumatoid arthritis for >=6 months;
- previous inadequate response to a single anti-TNF alpha inhibitor;
- methotrexate at a stable dose range 7.5-25mg/week.
Exclusion criteria:
- other chronic inflammatory articular disease or systemic autoimmune disease;
- previous treatment with MabThera or intolerance to MabThera;
- corticosteroids>=10mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2006
Trial registration date: 11/16/2006
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Bad Abbach
- Bad Aibling
- Bad Bramstedt
- Berlin
- Bonn
- Bremen
- Cuxhafen
- Damp
- Dresden
- Düsseldorf
- Erfurt
- Erlangen
- Essen
- Frankfurt Am Main
- Freiburg
- Fulda
- Giessen
- Gommern
- Göttingen
- Hagen
- Halle
- Hamburg
- Hannover
- Heidelberg
- Herne
- Hofheim
- Homburg
- Jena
- Karlsruhe
- Köln
- Ludwigshafen
- Mainz
- Mittelherwigsdorf
- Mönchengladbach
- München
- Münster
- Naunhof
- Oldenburg
- Osnabrück
- Pirna
- Ratingen
- Rostock
- Schwerte
- Sendenhorst
- Stuttgart
- Treuenbrietzen
- Trier
- Tübingen
- Ulm
- Villingen-Schwenningen
- Wiesbaden
- Wuppertal
- Würselen
- Würzburg
- Zeven
