A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Corticosteroid or NSAID; Drug: Methotrexate; Dietary Supplement: Folate; Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00462345

ML20934

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Rituximab, Methotrexate

Experimental group

Description:

Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate greater than or equal to (≥) 5 mg/week, PO, folate greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.

Treatment:

Dietary Supplement: Folate

Drug: rituximab

Drug: Corticosteroid or NSAID

Drug: Methotrexate