A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate; Drug: methylprednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000610

ML20549

Details and patient eligibility

About

In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is <50

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >/= 18 years of age
• rheumatoid arthritis DAS28 >/= 3.2
• receiving treatment on an outpatient basis
• experienced an inadequate response to previous or current treatment with methotrexate

Exclusion criteria

• rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
• history of or current inflammatory joint disease other than RA
• previous treatment with any cell-depleting therapies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

single arm

Experimental group

Treatment:

Drug: methotrexate

Drug: methylprednisolone

Drug: rituximab [MabThera/Rituxan]