Trial | NCT00291915  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)
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 Started
May 31
2004
Study Completion
Mar 31
2007
Last Update
Feb 15
2006
Estimate

Drug Adalimumab

Drug Methotrexate

Criteria 

Inclusion Criteria:

Early Active Potentially severe arthritis

Exclusion Criteria:

contra indication of methotrexate or anti TNF
No Results Posted