NCT00291915

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

Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (planned)
• Sponsor: Goupe d'Etudes et de Recherche Clinique En Rhumatologie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Rheumatoid Arthritis
• Arthritis

Interventions

Type	Name	Description
DRUG	Adalimumab
DRUG	Methotrexate

Timeline

• Start date: 2004-05-01
• Completion: 2007-03-01
• First posted: 2006-02-15
• Last updated: 2006-02-15

Locations

1 site across 1 country: France