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Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Goupe d'Etudes et de Recherche Clinique En Rhumatologie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Goupe d'Etudes et de Recherche Clinique En Rhumatologie
ClinicalTrials.gov Identifier:
NCT00291915
First received: February 14, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Goupe d'Etudes et de Recherche Clinique En Rhumatologie:

Primary Outcome Measures:
  • Disease Activity Score

Secondary Outcome Measures:
  • -Radiological score
  • -Functional impairment ( HAQ)
  • -Pain (VAS)

Estimated Enrollment: 80
Study Start Date: May 2004
Estimated Study Completion Date: March 2007
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Early Active Potentially severe arthritis

Exclusion Criteria:

  • contra indication of methotrexate or anti TNF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291915

Contacts
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

Locations
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            
Sponsors and Collaborators
Goupe d'Etudes et de Recherche Clinique En Rhumatologie
Investigators
Principal Investigator: Maxime DOUGADOS, MD Hopital Cochin Paris FRance
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291915     History of Changes
Other Study ID Numbers: GUEPARD-GERCER 2122
Study First Received: February 14, 2006
Last Updated: February 14, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Goupe d'Etudes et de Recherche Clinique En Rhumatologie:
early arthritis, methotrexate, adalimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013