Trial information
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy.
Status: Completed
Protocol number: ML20388
Sponsor: F. Hoffmann-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of MabThera in combination with methotrexate on disease activity in patients with active rheumatoid arthritis after DMARD treatment failure
Brief summary: This study will evaluate the efficacy and safety of MabThera plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 15.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Rheumatoid Arthritis
Primary outcome: 1. Disease activity (improvement of >0.6 in DAS 28)
Key secondary outcomes: 1. Adverse events, laboratory parameters, QoL.
Inclusion criteria:
- adult patients, 18-80 years of age;
- rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
- active disease;
- DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
Exclusion criteria:
- autoimmune disease other than rheumatoid arthritis;
- bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
- concurrent treatment with any DMARD or antiTNF-alfa;
- intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: August, 2006
Trial registration date: 09/18/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Serbia and Montenegro
- Belgrade
- Niska Banja
- Novi Sad
