A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-04-30

Brief Summary

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This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Participants will receive tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks in addition to their current DMARD therapy.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tocilizumab in Active RA

Participants with active RA will receive tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions will be given from Baseline to Week 44, and participants will be assessed through Week 48.

Group Type EXPERIMENTAL

DMARDs

Intervention Type DRUG

Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol.

Tocilizumab

Intervention Type DRUG

Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.

Interventions

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DMARDs

Participants may continue on a stable dose of their current DMARD therapy as prescribed. The choice of DMARD is at the discretion of the treating physician and is not specified by the protocol.

Intervention Type DRUG

Tocilizumab

Tocilizumab will be given as 8 mg/kg via IV infusion every 4 weeks for a total of 12 infusions. The maximum allowed dose is 800 mg.

Intervention Type DRUG

Other Intervention Names

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RoActemra, Actemra

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe active RA of ≥6 months duration
* DAS28 \>3.2
* Inadequate response to a stable dose of non-biologic DMARD for ≥2 months
* Those receiving oral corticosteroids must have been at stable dose for ≥25 days in the 28 days prior to first study treatment

Exclusion Criteria

* Rheumatic autoimmune disease other than RA
* History of or current inflammatory joint disease other than RA
* Previous treatment with alkylating agents or total lymphoid irradiation
* Intra-articular or parenteral corticosteroids within 6 weeks prior to Baseline
* Previous treatment with any cell-depleting therapies
* American College of Rheumatology (ACR) Functional Class IV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No