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: No longer recruiting
Protocol number: ML21271
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the safety and effect on treatment response of MabThera in patients with rheumatoid arthritis following inadequate response to one prior anti-TNF inhibitor
Brief summary: This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals. Target sample size is
100.
Study phase: IV
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. AEs, including infusion-related adverse events Time frame: For 48 weeks after initial treatment
Key secondary outcomes: 1. Safety of re-treatment (AEs) Time frame: For 24 weeks after re-treatment.
2. Laboratory parameters, vital signs. Time frame: Throughout study
3. ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT. Time frame: For 48 weeks after initial treatment.
Inclusion criteria:
- adult patients, 18-80 years of age;
- moderate to severe active rheumatoid arthritis;
- inadequate response to previous or current treatment with 1 anti-TNF agent;
- receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
Exclusion criteria:
- previous treatment with MabThera;
- use of an anti-TNF alpha agent within 8 weeks of study start;
- concurrent treatment with any DMARD other than methotrexate;
- active infection, or history of serious recurrent or chronic infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 12/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Russian Federation
- Chelyabinsk
- Ekaterinburg
- Irkutsk
- Kazan
- Khabarovsk
- Khanty-Mansiysk
- Krasnodar
- Kursk
- Moscow
- Nizhny Novgorod
- Novosibirsk
- Rostov-Na-Donu
- Ryazan
- St Petersburg
- Tjumen
- Ufa
- Vladivostok
- Voronezh
- Yaroslavl
