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

February 14, 2006 updated by: Goupe d'Etudes et de Recherche Clinique En Rhumatologie

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Recruiting
        • Hopital Cochin
        • Sub-Investigator:
          • Martin SOUBRIER
        • Contact:
        • Contact:
        • Principal Investigator:
          • maxime DOUGADOS, MD
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Early Active Potentially severe arthritis

Exclusion Criteria:

  • contra indication of methotrexate or anti TNF

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease Activity Score

Secondary Outcome Measures

Outcome Measure
-Radiological score
-Functional impairment ( HAQ)
-Pain (VAS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

Investigators

  • Principal Investigator: Maxime DOUGADOS, MD, Hopital Cochin Paris FRance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Estimate)

February 15, 2006

Last Update Submitted That Met QC Criteria

February 14, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUEPARD-GERCER 2122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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