Trial information
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.
Status: Recruiting
Protocol number: ML19071
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the safety of re-treatment with MabThera, and its effect on treatment response, in patients with rheumatoid arthritis following inadequate response to a single anti-TNF agent (extension study to ML19070).
Brief 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. Target sample size is 240.
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. Change of DAS 28 Time frame: Week 24
Key secondary outcomes: 1. ACR 20/50/70, HAQ, SF-36, FACIT-F, TJC, SJC, CRP, BSG, RF. Time frame: Week 24
2. AEs Time frame: Throughout study
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- patients who have withdrawn from treatment in ML19070 pre-week 16;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.
Gender: Males or Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 07/19/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Bad Aibling
- Bad Bramstedt
- Berlin
- Bernau
- Bonn
- Bremen
- Cuxhafen
- Düsseldorf
- Erfurt
- Erlangen
- Essen
- Frankfurt Am Main
- Freiburg
- Fulda
- Giessen
- Gommern
- Göttingen
- Hagen
- Halle
- Hamburg
- Hannover
- Heidelberg
- Herne
- Hofheim
- Homburg
- Jena
- Karlsruhe
- Kiel
- Köln
- Ludwigshafen
- Mainz
- Mittelherwigsdorf
- Mönchengladbach
- München
- Münster
- Naunhof
- Oldenburg
- Osnabrück
- Pirna
- Ratingen
- Regensburg
- Rostock
- Schwerte
- Sendenhorst
- Stuttgart
- Treuenbrietzen
- Trier
- Tübingen
- Ulm
- Villingen-Schwenningen
- Wiesbaden
- Wuppertal
- Würselen
- Würzburg
- Zeven
