A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Methotrexate

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109408

WA17824

Details and patient eligibility

About

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Enrollment

673 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients at least 18 years of age with active RA for at least 3 months;
patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria

major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
treatment with methotrexate (MTX) within 6 months of entering study;
patients who have stopped previous MTX treatment due to toxicity or lack of response;
women who are pregnant or breast-feeding.