A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00773461

ML21753

Details and patient eligibility

About

This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 209 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, 18-70 years of age;
• rheumatoid arthritis for >= 6 months;
• receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;
• current inadequate clinical response to DMARDs.

Exclusion criteria

• major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• unsuccessful treatment with an anti-TNF agent;
• previous treatment with tocilizumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]

2

Placebo Comparator group

Treatment:

Drug: Placebo