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Sponsors and Collaborators: |
University Hospital Birmingham Wyeth |
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Information provided by: | University Hospital Birmingham |
ClinicalTrials.gov Identifier: | NCT00523692 |
Rheumatoid arthritis (RA) is a debilitating chronic immune mediated inflammatory disease which affects 1% of the European population. RA is associated with significant joint damage, disability and an enhanced mortality. Current treatment strategies target patients once synovitis has been present for several months and it is clear that the patient has developed persistent disease. After the first 3 months of symptoms, we and others have shown that the persistence of chronic inflammation in the rheumatoid synovium is driven by hyperplastic stromal tissue which inhibits leukocyte apoptosis leading to the accumulation of inflammatory cells in the joint. Therapies at this stage of disease, with conventional disease modifying anti-rheumatic drugs (DMARDs) as well as drugs targeting TNF-alpha reduce disease activity but are unable to cure RA. We have now identified that the very early phase of synovitis in patients destined to develop RA (within the first 12 weeks of symptoms) represents a pathologically distinct phase of disease. This suggests that late disease is not just more of early disease and gives, for the first time, a clear rationale for very early intervention. Building on these recent observations, we propose to test the hypothesis that the disease processes in the very early stages of RA are fundamentally different to those in established chronic disease. This will be done by assessing whether treatment during this phase with the well-established gold standard modality of anti-TNF-alpha therapy and methotrexate can permanently switch off inflammation, preventing the development of RA and thereby effecting a cure of the disease.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Etanercept, methotrexate and depomedrone Drug: depemedrone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Remission Induction in Very Early Rheumatoid Arthritis: a Comparison of Etanercept Plus Methotrexate Plus Steroid With Standard Therapy |
Estimated Enrollment: | 20 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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1: Experimental
Intensive therapy
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Drug: Etanercept, methotrexate and depomedrone
Etanercept (50mg weekly; subcutaneous) Methotrexate (7.5-25mg weekly; oral) Depomedrone (up to 120mg; intraarticular / intramuscular)
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2: Active Comparator
Standard therapy
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Drug: depemedrone
depomedrone (up to 120mg im/ia) methotrexate (added after symptoms have been present for 12 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:
Contact: Karim Raza, MRCP PhD | 00 44 1214143837 | k.raza@bham.ac.uk |
United Kingdom, West Midlands | |
Sandwell and West Birmingham Hospitals NHS Trust | |
Birmingham, West Midlands, United Kingdom, B18 7QH | |
University Hopsital Birmingham NHS Foundation Trust | |
Birmingham, West Midlands, United Kingdom, B15 2TH |
Principal Investigator: | Karim Raza, MRCP PhD | University of Birmingham |
Study Director: | Christopher D Buckley, FRCP PhD | University of Birmingham |
Study ID Numbers: | RRK2939, REC reference 06/Q2404/95, EudraCT number 2006-001428-38, CTA number 16719/0201/001-0001 |
Study First Received: | August 30, 2007 |
Last Updated: | August 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00523692 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Early arthritis Rheumatoid arthritis Rheumatoid factor Anti CCP antibody |
Remission Anti-TNF therapy methotrexate |
Folic Acid Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases TNFR-Fc fusion protein Immunoglobulins |
Antimetabolites Anti-Inflammatory Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Sensory System Agents Therapeutic Uses Abortifacient Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immune System Diseases Gastrointestinal Agents Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |