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

NCT ID: NCT00291915

Last Updated: 2006-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Rheumatoid Arthritis Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Adalimumab

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Early Active Potentially severe arthritis

Exclusion Criteria

* contra indication of methotrexate or anti TNF
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goupe d'Etudes et de Recherche Clinique En Rhumatologie

OTHER

Sponsor Role lead

Principal Investigators

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Maxime DOUGADOS, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Cochin Paris FRance

Locations

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Hopital Cochin

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maxime r DOUGADOS, MD

Role: CONTACT

[email protected]
00 33 1 58 41 25 62

Martin SOUBRIER, MD

Role: CONTACT

[email protected]
00 33 6 81 74 78 85

Facility Contacts

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Maxime DOUGADOS, md

Role: primary

[email protected]
00 33 1 58 41 25 62

Martin SOUBRIER, MD

Role: backup

msoubrier@chu-clermond ferrand.fr
00 33 6 81 74 78 85

Other Identifiers

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GUEPARD-GERCER 2122

Identifier Type: -

Identifier Source: org_study_id