An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00750880

2008-000587-17

MA21573

Details and patient eligibility

About

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Enrollment

1,681 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

male and non-pregnant or nursing female patients >=18 years of age;
body weight <=150kg;
moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.

Exclusion criteria

major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
rheumatic autoimmune disease other than RA;
prior history of, or current inflammatory joint disease other than RA;
functional class IV as defined by the ACR Classification of Functional Status in RA.