Trial information
A Quality of Life Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Status: Completed
Protocol number: ML18238
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open label study of the effect of MabThera on quality of life and treatment response in patients with rheumatoid arthritis.
Brief summary: This study will compare the quality of life in patients with rheumatoid arthritis treated with MabThera + methotrexate versus methotrexate + DMARD; efficacy will also be assessed. Patients will be randomized into one of 3 groups to receive 1) MabThera (1g iv on days 1 and 15) + methotrexate (15mg po weekly) from weeks 12 - 24 in the absence of an ACR 50 response at week 12, 2) MabThera (1g iv on days 1 and 15) concomitantly with >=15mg methotrexate po weekly or 3) methotrexate (>=15mg po weekly) + a second DMARD. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 98.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Quality of Life (RA Development Index, SF36, HAQ, EuroQoL, WHODASII) at week 24.
Key secondary outcomes: 1. Efficacy: ACR 20/50/70 responses at week 24. Safety: AEs, laboratory tests.
Inclusion criteria:
- adult patients, >=18 years of age;
- diagnosis of rheumatoid arthritis, for >=6 months;
- lack of response to 1-5 DMARDS.
Exclusion criteria:
- chronic inflammatory articular disease or systemic rheumatic disease other than RA;
- previous treatment with any cell depleting therapy;
- history of severe reactions to murine or humanized monoclonal antibodies.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Mexico
- Guadalajara
- Hermosillo, Sonora
- Mexico City
- Monterrey
- San Luis Potosi
