drugset / Trial / NCT01724268

Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient

NCT01724268

Phase 3 Unknown 80 enrolled Hamad Medical Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of adding one of the available anti TNF in the treatment of methotrexate inadequate responder rheumatoid arthritis patient. Hypothesis: Methotrexate + Prednisolone vs. Methotrexate + anti TNF

Timeline

Start
2012-05
Primary completion
2014-05
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg
Comparator Etanercept Protein / enzyme biologic 50 mg
Comparator Infliximab Monoclonal antibody 3 mg/kg
Subject Prednisolone Other / unclassified 10 mg Oral
Background Methotrexate Small molecule 25 mg

Indications