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

NCT02006706

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: rituximab [MabThera/Rituxan], methotrexate, methylprednisolone

Countries: Serbia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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* DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.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.

Locations (3)

Belgrade, Serbia
Niška Banja, Serbia
Nova Sad, Serbia