A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01353859

ML25536

Details and patient eligibility

About

This multicenter, open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with active rheumatoid arthritis who have an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for a total of 6 infusions plus methotrexate 10-25 mg orally weekly. Anticipated time on study treatment is 24 weeks.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
Moderate to severe active rheumatoid arthritis (RA) of >/= 6 months duration
Prior treatment with DMARDs for >/= 12 weeks (at stable dose for >/= 8 weeks)
Inadequate clinical response to stable dose of non-biologic DMARD (either single or in combination)

Exclusion criteria

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
Autoimmune disease other than RA
History of or current inflammatory joint disease other than RA
Previous treatment with any biologic drug that is used in the treatment of RA
Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline
Impaired liver, renal or hematologic function
Active current or history of recurrent infection
History of or currently active primary or secondary immunodeficiency