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Sponsors and Collaborators: |
Schering-Plough AESCA Pharma GmbH |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00521924 |
This Phase 3, randomized, open-label, multicenter study in rheumatoid arthritis (RA) patients with low disease activity (DAS 28 >2.8 and <3.5) is being conducted to evaluate induction of remission by adding infliximab to pre-existing treatment versus no additional treatment. All subjects eligible for this study, aged >35 to <=65 years, will have a diagnosis of RA according to ACR criteria, and will be offered additional treatment with infliximab. Prior to the start of treatment, subjects must be on a stable regimen of disease modifying antirheumatic drugs (DMARDs) for at least 3 months. Subjects will be randomized (1:1) to basic therapy with or without infliximab for a total duration of 38 weeks followed by a follow-up period of up to 6 months. Subjects randomized to basic therapy + infliximab will receive infliximab 3 mg/kg at Weeks 0, 2, 6, 14, 22, 30, and 38. The primary objective of the study is to assess the rate of remission according to DAS 28 (<2.6) at the end of treatment (after 38 weeks). Safety assessments include the incidence of adverse events, serious adverse events, and clinically notable abnormal vital signs and laboratory values.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Biological: infliximab Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89. |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Induction of Remission in RA Patients at Low Disease Activity by Additional Infliximab-Therapy |
Estimated Enrollment: | 160 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Experimental
3 mg/kg infliximab plus basic treatment
|
Biological: infliximab
infliximab 3 mg/kg and basic treatment
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Basic treatment (DMARDs): Active Comparator
Rheumatoid Arthritis basic therapy (DMARDs)
|
Drug: DMARDs (methotrexate; chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89.
Methotrexate (15 - 25 mg/week); chloroquine; leflunomidum; cyclosporin A; sulfasalazine; OM 89
|
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they met any of the following criteria:
Principal Investigator: | Burkhard F. Leeb, MD | Lower Austrian Center for Rheumatology; Landesklinikum Weinviertel-Stockerau; Director of the Karl Landersteiner Institute |
Responsible Party: | Schering-Plough ( Gerhard Wildauer, MD - Medical Director, Austria Country Operations ) |
Study ID Numbers: | P04644, 2005-004530-40 |
Study First Received: | August 27, 2007 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00521924 History of Changes |
Health Authority: | Austria: AGES; Austria: GmbH |
Anti-Inflammatory Agents Antimetabolites Cyclosporine Immunologic Factors Infliximab Clotrimazole Sulfasalazine Miconazole Arthritis, Rheumatoid Cyclosporins Antimalarials Musculoskeletal Diseases Arthritis Antifungal Agents Connective Tissue Diseases |
Methotrexate Anti-Inflammatory Agents, Non-Steroidal Analgesics Autoimmune Diseases Joint Diseases Tioconazole Chloroquine Rheumatic Diseases Folic Acid Antagonists Immunosuppressive Agents Folic Acid Analgesics, Non-Narcotic Chloroquine diphosphate Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antiprotozoal Agents Antimetabolites, Antineoplastic Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Infliximab Sulfasalazine Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Cyclosporins |
Antimalarials Antiparasitic Agents Musculoskeletal Diseases Sensory System Agents Antifungal Agents Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases Methotrexate Anti-Inflammatory Agents, Non-Steroidal Analgesics Amebicides Dermatologic Agents Nucleic Acid Synthesis Inhibitors |