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

Phase 4

• Conditions: Rheumatoid Arthritis; Arthritis

• Registration Number: NCT00291915
• Lead Sponsor: Goupe d'Etudes et de Recherche Clinique En Rhumatologie

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

Study Timeline

• Study Start: 2004-05
• Status Verified: 2006-02
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Last Update Submitted: 2006-02-14
• Study First Posted: 2006-02-15
• Last Update Posted: 2006-02-15
• Study Completion: 2007-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Early Active Potentially severe arthritis

Exclusion Criteria

• contra indication of methotrexate or anti TNF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease Activity Score

Secondary Outcome Measures

Name	Time	Method
-Radiological score
-Functional impairment ( HAQ)
-Pain (VAS)

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France