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Sponsors and Collaborators: |
Schering-Plough Integrated Therapeutics Group |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00394589 |
This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.
Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion. A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Infliximab Control Drug: Infliximab Increased Frequency Drug: Infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised Controlled Trial Evaluating Strategies to Optimize Disease Activity Control in RA Patients Treated With Infliximab in Clinical Practice. |
Estimated Enrollment: | 315 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator
Continuation of Infliximab 3 mg/kg every 8 weeks
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Drug: Infliximab Control
Continue infliximab 3 mg/kg every 8 weeks for 24 weeks
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Increased Frequency: Experimental
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
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Drug: Infliximab Increased Frequency
Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks
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Increased Dose: Experimental
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks
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Drug: Infliximab
3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks for 24 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04249 |
Study First Received: | October 31, 2006 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00394589 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women; Belgium: Ministry of Social Affairs, Public Health and the Environment; Denmark: Danish Medicines Agency; France: Ministry of Health; Germany: Paul-Ehrlich-Institut; Greece: Ministry of Health and Welfare; Netherlands: Medicines Evaluation Board (MEB); Norway: Norwegian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Sweden: Medical Products Agency; Turkey: Ministry of Health |
Anti-Inflammatory Agents Autoimmune Diseases Musculoskeletal Diseases Infliximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Antirheumatic Agents |
Anti-Inflammatory Agents Autoimmune Diseases Immune System Diseases Infliximab Joint Diseases Arthritis, Rheumatoid Gastrointestinal Agents Rheumatic Diseases |
Pharmacologic Actions Musculoskeletal Diseases Arthritis Therapeutic Uses Connective Tissue Diseases Antirheumatic Agents Dermatologic Agents |