Trial information
A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.
Status: No longer recruiting
Protocol number: ML19385
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An expanded access program to assess the safety of MabThera in patients with rheumatoid arthritis
Brief summary: This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 350.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Rheumatoid Arthritis
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. Adverse event incidence and profile Time frame: Throughout study
Key secondary outcomes: 1. None Time frame: None
Inclusion criteria:
- adult patients, >=18 years of age;
- rheumatoid arthritis >=6 months;
- lack of response to 1-5 DMARDs or biological agents;
- rheumatoid factor positive.
Exclusion criteria:
- other chronic inflammatory articular disease or systemic rheumatic disease;
- joint or bone surgery during 8 weeks prior to randomization;
- previous treatment with any cell-depleting therapy.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2006
Trial registration date: 07/19/2007
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Argentina
- Buenos Aires
- Córdoba
- Tucuman
Brazil
- Belem
- Brasilia
- Campinas
- Curitiba
- Fortaleza
- Goiania
- Nova Lima
- Porto Alegre
- Recife
- Rio De Janeiro
- Salvador
- Sao Paulo
- Vitoria
Chile
Colombia
Ecuador
El Salvador
Mexico
- Mexico City
- San Luis Potosi
Peru
- Jesus Maria
- Lima
- San Isidro
Uruguay
Venezuela
