A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006706

ML20388

Details and patient eligibility

About

This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-80 years of age;
• rheumatoid arthritis after inadequate response to >=1 DMARD treatment;
• active disease;
• DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.

Exclusion criteria

• autoimmune disease other than rheumatoid arthritis;
• bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion;
• concurrent treatment with any DMARD or antiTNF-alfa;
• intra-articular or parenteral corticosteroids within 4 weeks prior to screening.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MabThera/Rituxan

Experimental group

Treatment:

Drug: methylprednisolone

Drug: rituximab [MabThera/Rituxan]

Drug: methotrexate