Rheumatoid Arthritis Clinical Trial
Official title:
A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance
Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone
Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20
mg weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus
methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly
titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate
rapidly titrated to 20 mg weekly
Follow up period - Open Label phase:
Patients achieving clinical remission will be than treated only with MTX and observed for
another 12 months period. Patients who do not achieve clinical remission or patients who
will experience a relapse of the disease will be treated according to standard of care (SOC)
modalities.
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