Status:
COMPLETED
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 in combination with methotrexate (MTX) after three in...
Eligibility Criteria
Inclusion
- Patients with active RA in spite of stable dose of MTX
Exclusion
- Having received infliximab in the past
- Having a history of serious infection which caused hospitalization within 6 months before the registration
- Having an active tuberculosis
- Having a complication or a history of malignancy within 5 years before the registration
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT00691028
Start Date
September 1 2005
End Date
May 1 2007
Last Update
January 7 2026
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