Trial information
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to anti-TNF Agents.
Status: No longer recruiting
Protocol number: ML20798
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 combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents.
Brief summary: This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 40.
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. Adverse event incidence and profile Time frame: Throughout study
Key secondary outcomes: 1. Change in DAS 28 Time frame: Week 24
2. ACR / EULAR 20/50/70 / HAQ Time frame: Week 24
Inclusion criteria:
- adult patients, >=18 years of age;
- active rheumatoid arthritis;
- receiving outpatient treatment;
- an inadequate response, or intolerance, to >=1 anti-TNF agent.
Exclusion criteria:
- other rheumatic autoimmune disease or inflammatory joint disease;
- concurrent treatment with any anti-TNF-alpha therapy;
- joint or osseous surgery during 8 weeks prior to recruitment.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 07/19/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Taiwan
- Changhua
- Kaohsiung
- Taichung
- Taipei
- Taoyuan
