NCT04027101

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polymyalgia Rheumatic (PMR)

Interventions

Type	Name	Description
DRUG	Baricitinib	patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12
DRUG	Placebos	patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2019-07-19
• Last updated: 2023-11-29

Locations

8 sites across 1 country: France