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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-02-13

Brief Summary

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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.

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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

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Interventions

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tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No