A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Roche

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: methotrexate

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01399697

ML27828

Details and patient eligibility

About

This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.

Enrollment

261 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
Body weight < 150 kg
Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion criteria

Pregnant or nursing women
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
Rheumatic autoimmune disease other than RA
Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
Prior history of or current inflammatory joint disease other than RA
Treatment with a biologic agent at any time prior to baseline
Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
Previous treatment with RoActemra/Actemra
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Known active current or history of recurrent infection
History of or currently active primary or secondary immunodeficiency
Active tuberculosis requiring treatment within the previous 3 years
Positive for HIV infection