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| Sponsored by: |
Goupe d'Etudes et de Recherche Clinique En Rhumatologie |
|---|---|
| Information provided by: | Goupe d'Etudes et de Recherche Clinique En Rhumatologie |
| ClinicalTrials.gov Identifier: | NCT00291915 |
Purpose
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Arthritis |
Drug: Adalimumab Drug: Methotrexate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | March 2007 |
Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maxime r DOUGADOS, MD | 00 33 1 58 41 25 62 | maxime.dougados@cch.aphp.fr |
| Contact: Martin SOUBRIER, MD | 00 33 6 81 74 78 85 | msoubrier@chu-clermontferrand.fr |
| France | |
| Hopital Cochin | Recruiting |
| Paris, France, 75014 | |
| Contact: Maxime DOUGADOS, md 00 33 1 58 41 25 62 maxime.dougados@cch.aphp.fr | |
| Contact: Martin SOUBRIER, MD 00 33 6 81 74 78 85 msoubrier@chu-clermond ferrand.fr | |
| Principal Investigator: maxime DOUGADOS, MD | |
| Sub-Investigator: Martin SOUBRIER | |
| Sub-Investigator: Bernard COMBE, MD | |
| Sub-Investigator: Jean SIBILIA, MD | |
| Sub-Investigator: Olivier MEYER, MD | |
| Sub-Investigator: Xavier PUECHAL, MD | |
| Sub-Investigator: Françis BERENBAUM, PhD | |
| Sub-Investigator: Xavier MARIETTE, MD | |
| Sub-Investigator: Patrice FARDELLONE, MD | |
| Sub-Investigator: René Marc FLIPO, MD | |
| Sub-Investigator: Philippe GOUPILLE, PhD | |
| Sub-Investigator: Thierry SCHAEVERBEKE, PhD | |
| Sub-Investigator: C ZARNITSKY, MD | |
| Principal Investigator: | Maxime DOUGADOS, MD | Hopital Cochin Paris FRance |
More Information
| Study ID Numbers: | GUEPARD-GERCER 2122 |
| Study First Received: | February 14, 2006 |
| Last Updated: | February 14, 2006 |
| ClinicalTrials.gov Identifier: | NCT00291915 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
early arthritis, methotrexate, adalimumab |
|
Anti-Inflammatory Agents Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Adalimumab |
Folic Acid Antagonists Immunosuppressive Agents Folic Acid Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
|
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Adalimumab Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents |
Connective Tissue Diseases Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |
