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

Goupe d'Etudes et de Recherche Clinique En Rhumatologie

Status and phase: Unknown; Phase 4

Conditions: Arthritis; Rheumatoid Arthritis

Treatments: Drug: Methotrexate; Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00291915

GUEPARD-GERCER 2122

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early Active Potentially severe arthritis

Exclusion criteria

• contra indication of methotrexate or anti TNF

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)