A Phase 3 interventional study of Placebo and Infliximab 3 mg/kg in Rheumatoid Arthritis, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-04.
Sponsored by Centocor, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.
This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..
Patients will be treated with either infliximab or matching placebo.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 428 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Drug: Placebo
Infliximab 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Drug: Infliximab 3 mg/kg
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
Drug: Infliximab 3 mg/kg
Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Drug: Infliximab 10 mg/kg
Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
Drug: Infliximab 10 mg/kg
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Also known as: anti-TNF chimeric monoclonal antibody (cA2)
Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
Also known as: anti-TNF chimeric monoclonal antibody (cA2)
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
Time frame: Baseline and Week 30
safety
Time frame: up to Week 54
No study locations are listed for this record.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Centocor, Inc.