drugset / Trial / NCT00480272

Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

NCT00480272

Phase 4 Completed 251 enrolled Fondazione IRCCS Policlinico San Matteo di Pavia
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2007-05
Primary completion
2017-03-01
Completion
2017-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject Prednisone Other / unclassified 6.25 mg Oral
Background Methotrexate Small molecule 20 mg Oral

Indications