Overview

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Status:
Recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
Patients with recent PMR(6 months or less) with a PMR-AS >17 and no oral or parenteral GCs during the past 2 weeks (at least) will be included. Treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if PMR-AS≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment. No rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of GCs until week 4 according to investigator's opinion. From week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to PMR-AS.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital, Brest
Collaborator:
Eli Lilly and Company