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 Therapies.
Status: No longer recruiting
Protocol number: ML20934
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of MabThera in combination with methotrexate on treatment response in patients with active rheumatoid arthritis who have had an inadequate response to anti-TNF therapies
Brief summary: This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. 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. After week 24, eligible patients may receive re-treatment. 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. Percentage of patients with ACR 20 response Time frame: Week 24
Key secondary outcomes: 1. ACR 50/70; change in DAS; EULAR response; changes in ACR core set; SF-36; radiographic analysis. Time frame: Week 24
2. AEs, laboratory parameters, immunology parameters Time frame: Throughout study
Inclusion criteria:
- adult patients, 18-80 years of age;
- rheumatoid arthritis for >=6 months;
- receiving outpatient treatment;
- an inadequate response to at least one anti-TNF therapy;
- stable methotrexate for >=12 weeks.
Exclusion criteria:
- other rheumatic autoimmune disease or inflammatory joint disease;
- previous treatment with MabThera;
- concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Gender: Males or Females
Age limits: Min: 18 Years Max: 80 Years
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 04/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Korea, Republic of
