Status:
COMPLETED
RESTART C0168Z05 Rheumatoid Arthritis Study
Lead Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Collaborating Sponsors:
Schering-Plough
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanerce...
Detailed Description
This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate respo...
Eligibility Criteria
Inclusion
- Patients must have rheumatoid arthritis
- Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
- Patients must have inadequate disease response to etanercept or adalimumab
- Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.
Exclusion
- Patients who have a history of latent or active TB
- Have inflammatory disease other than rheumatoid arthritis
- Have had a chronic or recurrent infectious disease.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00714493
Start Date
July 1 2008
End Date
June 1 2010
Last Update
September 12 2013
Active Locations (76)
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1
Huntsville, Alabama, United States
2
Paradise Valley, Arizona, United States
3
Tucson, Arizona, United States
4
Santa Monica, California, United States