A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848120

ML22074

Details and patient eligibility

About

This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients,>=18 years of age;
• rheumatoid arthritis diagnosed >8 weeks and <4 years prior to baseline;
• naive to, or not responding well to, methotrexate;
• swollen joint count >=8 (66 joint count) and tender joint count>=8 (68 joint count) at screening and baseline.

Exclusion criteria

• rheumatic autoimmune disease other than rheumatoid arthritis;
• patients with functional class IV rheumatoid arthritis;
• history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

1

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]