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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-07-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8mg/kg iv every 4 weeks for 24 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

iv every 4 weeks for 24 weeks

Interventions

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tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 24 weeks

Intervention Type DRUG

Placebo

iv every 4 weeks for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No