Justification AnD evaluation, in pOlymyalgia RhEumatica, of BARIcitinib versus placebo (JADORE-BARI study)

2024-518385-26-01 · tracked via the Priya Life Science EU tracker

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor type

Hospital/Clinic/Other health care facility

Therapeutic area

Immune System Diseases

Decision date

07/10/2025

Enrollment target

140

Sites

France

Condition studied

Polymyalgia Rheumatica (PMR)

Investigational medicinal product(s)

tablets containing placebo to match 4 mg baricitinibtablets containing placebo to match 2 mg baricitinibOlumiant 4 mg film-coated tabletsOlumiant 2 mg film-coated tablets

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

The primary outcome is a PMR-AS (CRP) ≤10 (no flare) without steroids at week 24.

Endpoint detail

PMR-AS (CRP) ≤10 (no flare) without steroids at week 24, PMR-AS (CRP) ≤10 (no flare) without steroids at week 12, PMR-AS (CRP) ≤10 (no flare) without steroids at week 12, PMR-AS (CRP) ≤10 (no flare) without steroids at week 24, PMR-AS (CRP) ≤10 (no flare) without steroids at week 12, Exploratory End Points (see synopsis), PMR-AS (CRP) ≤10 (no flare) without steroids at week 36, PMR-AS (CRP) ≤10 (no flare) without steroids at week 36, PMR-AS (CRP) ≤10 (no flare) without steroids at week 36

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-518385-26-01 on CTIS ↗ ← All trials in the EU