A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
Status: | Completed |
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Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2016 |
Start Date: | April 2005 |
End Date: | December 2007 |
A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and
symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying
Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid
arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will
be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction
with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the
target sample size is 500+ individuals.
symptoms, of tocilizumab versus placebo in combination with traditional Disease-Modifying
Anti-Rheumatic Drug (DMARD) therapy in patients with moderate to severe active rheumatoid
arthritis (RA) who have had an inadequate response to current DMARD therapy. Patients will
be randomized to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction
with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the
target sample size is 500+ individuals.
Inclusion Criteria:
- 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 1 or more
traditional DMARDs;
- stable DMARD therapy 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 entering study, or
planned surgery within 6 months after entering study;
- patients who have previously failed treatment with an anti-tumor necrosis factor
agent;
- women who are pregnant or breast-feeding.
We found this trial at
75
sites
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