Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 673 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States, Argentina, Australia, Canada, China, Denmark, France, Israel, Italy, Lithuania, Mexico, Norway, Peru, Portugal, Serbia, Slovenia, South Africa, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients with ACR 20 response | Week 24 | No | |
Secondary | Percentage of patients with ACR 20 response | Week 8 | No | |
Secondary | Percentage of patients with ACR 50 and ACR 70 responses | Week 24 | No | |
Secondary | Mean change in parameters of ACR core set | Week 24 | No | |
Secondary | AEs, laboratory parameters, vital signs. | Throughout study | No |
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