Early Phase Study to Assess Efficacy and Safety of AZD9567 Versus Prednisolone in Patients With Rheumatoid Arthritis
Status:
Completed
Trial end date:
2019-11-12
Target enrollment:
Participant gender:
Summary
This is a phase 2a study to be run in 2-3 countries in European Union involving 5-6 sites. It
will enroll approximately 80 patients to ensure 40 randomized with active rheumatoid
arthritis. The treatment period is 2 weeks and total study duration per patient is
approximately 1 month. The study drugs are AZD9567 40 mg (an oral SGRM) and the comparator is
prednisolone 20mg. The primary endpoint is DAS28 including evaluation of 28 joints and
C-reactive protein. Safety parameters will also be evaluated and a biomarker program is
included for future research.