Comparison of the Effectiveness of Two Different Dosages of Cortisone Compared to Placebo in Rheumatoid Arthritis
Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
Participant gender:
Summary
Although cortisone is widely used in the treatment of patients with early rheumatoid
arthritis, the best dosage is not known. Therefore we will compare two standard prednisolon
starting dosages and placebo in the treatment of patients with early active rheumatoid
arthritis on the background of the established therapy with methotrexate. In total 450
patients will be included into the study. Two different treatment arms starting with 10 or 60
mg of prednisolone, and one placebo arm. Duration of intervention is 12 weeks. In parallel,
all patients start medication with methotrexate, usual dosage 15 mg/week. Primary efficacy
endpoint is progression of radiographic damage after one year compared to baseline. Safety
monitoring is performed.