|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| 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 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
early arthritis, methotrexate, adalimumab |
|
Folic Acid Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Methotrexate Rheumatic Diseases Adalimumab |
|
Anti-Inflammatory Agents Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
