A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-09-30

Brief Summary

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This randomized, double-blind, placebo-controlled study will use Magnetic Resonance Imaging (MRI) to assess the efficacy of tocilizumab plus non-biological DMARD in patients with moderate to severe rheumatoid arthritis who have had an inadequate response to non-biological DMARDS. Patients will be randomized to receive either intravenous tocilizumab at 8mg/kg (minimal dose 480mg, maximum dose 800mg) or placebo every 4 weeks, in addition to their stable dose of non-biological DMARD. Anticipated time on study treatment is 24 weeks, and target sample size is \<100.

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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 (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks

non-biological DMARDs

Intervention Type DRUG

stable dose at investigator's prescription

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

iv every 4 weeks for 24 weeks

non-biological DMARDs

Intervention Type DRUG

stable dose at investigator's prescription

Interventions

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tocilizumab [RoActemra/Actemra]

8mg/kg (minimal dose 480mg, maximum dose 800mg) iv infusion every 4 weeks for 24 weeks

Intervention Type DRUG

placebo

iv every 4 weeks for 24 weeks

Intervention Type DRUG

non-biological DMARDs

stable dose at investigator's prescription

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis of \>/=6 months duration
* synovitis (swollen and tender joint) in the wrist of the dominant hand
* non-biologic DMARDs at stable dose for \>/=12 weeks prior to baseline
* oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria

* rheumatic autoimmune disease other than RA
* history of or current inflammatory joint disease other than RA
* functional class IV (ACR classification)
* intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
* previous treatment with a biologic agent for RA

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No