A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:July 2005
End Date:December 2007

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A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus
methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized
to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate
7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is
3-12 months and the target sample size is 500+ individuals.


Inclusion Criteria:

- adult patients at least 18 years of age with active RA for at least 3 months;

- patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

- major surgery (including joint surgery) within 8 weeks before entering study or
planned major surgery within 6 months after entering study;

- treatment with methotrexate (MTX) within 6 months of entering study;

- patients who have stopped previous MTX treatment due to toxicity or lack of response;

- women who are pregnant or breast-feeding.
We found this trial at
67
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Charleston, South Carolina 29412
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Duncansville, Pennsylvania 16635
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Eagan, MN
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Fayetteville, North Carolina 28304
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Flowood, MS
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Grand Rapids, MI
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Greenbelt, MD
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Greenville, South Carolina 29605
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Haddon Heights, New Jersey 08035
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Huntington Beach, California 92646
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New Brunswick, New Jersey 08901
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Pittsfield, Massachusetts 01201
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