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

Primary Purpose

Rheumatoid Arthritis, Arthritis

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Adalimumab

Methotrexate

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring early arthritis, methotrexate, adalimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Early Active Potentially severe arthritis Exclusion Criteria: contra indication of methotrexate or anti TNF

Sites / Locations

Hopital CochinRecruiting

Outcomes

Primary Outcome Measures

Disease Activity Score

Secondary Outcome Measures

-Radiological score

-Functional impairment ( HAQ)

-Pain (VAS)

Full Information

NCT ID

NCT00291915

First Posted

February 14, 2006

Last Updated

February 14, 2006

Sponsor

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

1. Study Identification

Unique Protocol Identification Number

NCT00291915

Brief Title

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

Official Title

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2006

Overall Recruitment Status

Unknown status

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

4. Oversight

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Arthritis

Keywords

early arthritis, methotrexate, adalimumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Primary Outcome Measure Information:

Title

Disease Activity Score

Secondary Outcome Measure Information:

Title

-Radiological score

Title

-Functional impairment ( HAQ)

Title

-Pain (VAS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Early Active Potentially severe arthritis Exclusion Criteria: contra indication of methotrexate or anti TNF

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maxime r DOUGADOS, MD

Phone

00 33 1 58 41 25 62

maxime.dougados@cch.aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Martin SOUBRIER, MD

Phone

00 33 6 81 74 78 85

msoubrier@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maxime DOUGADOS, MD

Organizational Affiliation

Hopital Cochin Paris FRance

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Cochin

City

Paris

ZIP/Postal Code

75014

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maxime DOUGADOS, md

Phone

00 33 1 58 41 25 62

maxime.dougados@cch.aphp.fr

First Name & Middle Initial & Last Name & Degree

Martin SOUBRIER, MD

Phone

00 33 6 81 74 78 85

msoubrier@chu-clermond ferrand.fr

First Name & Middle Initial & Last Name & Degree

maxime DOUGADOS, MD

First Name & Middle Initial & Last Name & Degree

Martin SOUBRIER

First Name & Middle Initial & Last Name & Degree

Bernard COMBE, MD

First Name & Middle Initial & Last Name & Degree

Jean SIBILIA, MD

First Name & Middle Initial & Last Name & Degree

Olivier MEYER, MD

First Name & Middle Initial & Last Name & Degree

Xavier PUECHAL, MD

First Name & Middle Initial & Last Name & Degree

Françis BERENBAUM, PhD

First Name & Middle Initial & Last Name & Degree

Xavier MARIETTE, MD

First Name & Middle Initial & Last Name & Degree

Patrice FARDELLONE, MD

First Name & Middle Initial & Last Name & Degree

René Marc FLIPO, MD

First Name & Middle Initial & Last Name & Degree

Philippe GOUPILLE, PhD

First Name & Middle Initial & Last Name & Degree

Thierry SCHAEVERBEKE, PhD

First Name & Middle Initial & Last Name & Degree

C ZARNITSKY, MD

12. IPD Sharing Statement

Learn more about this trial

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

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