BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborator: Eli Lilly and Company

Criteria

Inclusion Criteria:

• At least 50 years of age

• Fulfilling ACR/EULAR criteria for PMR

• Disease duration ≤6 months

• No oral or parenteral steroid since ≥ 2 weeks prior to randomization

• PMR-AS >17

• Absence of connective tissue diseases or vasculitis

• Able to give informed consent

Exclusion Criteria:

• Clinical symptoms of giant cell arteritis

• Uncontrolled high blood pressure or cardiovascular disease

• Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR

• Planned major surgical procedure during the study.

• History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease).

• Current active uncontrolled infection

• Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol