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

Rheumatoid Arthritis Clinical Trial

Official title:
Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Clinical Trial Summary

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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00291915
Study type Interventional
Source Goupe d'Etudes et de Recherche Clinique En Rhumatologie
Contact Maxime r DOUGADOS, MD
Phone 00 33 1 58 41 25 62
Email maxime.dougados@cch.aphp.fr
Status Recruiting
Phase Phase 4
Start date May 2004
Completion date March 2007
View Details
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