Status:
COMPLETED
An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes...
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study compari...
Eligibility Criteria
Inclusion
- Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the American College of Rheumatology Criteria 1987
- Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for at least 4 weeks
- Participants using oral corticosteroids, must have been on a stable dose of prednisone less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before screening or if currently not using corticosteroids, the participant must not have received corticosteroids for at least 4 weeks before screening
- Participants with moderate to severe RA (Disease Activity Score \[DAS28\] greater than 3.2)
- Male participants shall adopt contraceptive measures during the trial and within 6 months after the completion of trial (such as spermicidal barrier), or their female sexual partners shall agree to adopt effective contraceptive measures during the trial or within 6 months after the completion of trial (such as oral contraceptives, contraceptives for injection, intrauterine device \[IUD\], or sterilization by surgery); female participants of childbearing potential with negative urine pregnancy test upon enrollment in addition to adopting the said contraceptive measures
Exclusion
- Participant who has a known allergy to human immunoglobulin proteins or other components of infliximab
- Participant who has a history of receiving infliximab or any other biological preparations
- Participant who is in stage IV RA evaluated by X-ray
- Participants suffering from tuberculosis
- Female participant or male participant's wife who plans to become pregnant during this study and within 6 months after completion of this study
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00896168
Start Date
June 1 2007
End Date
April 1 2008
Last Update
September 13 2013
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