A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy



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

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A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and
symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients
with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who
have had an inadequate response to prior therapy with an anti-tumor necrosis factor
(anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab
8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate
10-25mg/week. 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 moderate to severe active RA for at
least 6 months;

- inadequate response to current anti-rheumatic therapies, including MTX;

- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies
within 1 year of entering study;

- on stable MTX for at least 8 weeks before entering study;

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

Exclusion Criteria:

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

- women who are pregnant or breast-feeding.
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