We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00291915
Recruitment Status : Unknown
Verified February 2006 by Goupe d'Etudes et de Recherche Clinique En Rhumatologie.
Recruitment status was:  Recruiting
First Posted : February 15, 2006
Last Update Posted : February 15, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Arthritis Drug: Adalimumab Drug: Methotrexate Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis
Study Start Date : May 2004
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Disease Activity Score

Secondary Outcome Measures :
  1. -Radiological score
  2. -Functional impairment ( HAQ)
  3. -Pain (VAS)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Early Active Potentially severe arthritis

Exclusion Criteria:

  • contra indication of methotrexate or anti TNF
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00291915     History of Changes
Other Study ID Numbers: GUEPARD-GERCER 2122
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: February 15, 2006
Last Verified: February 2006

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
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