Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
140
Countries
1
Sites
22
Polymyalgia Rheumatica (PMR)
To demonstrate the ability of baricitinib 4 mg plus short GCs treatment in comparison to placebo plus short GCs treatment to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) at week 24 in PMR patients.
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 18 Dec 2025 → ongoing
- Decision date (initial)
- 2025-10-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Eli Lilly and Company (Lilly)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To demonstrate the ability of baricitinib 4 mg plus short GCs treatment in comparison to placebo plus short GCs treatment to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) at week 24 in PMR patients.
Secondary objectives 9
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients of baricitinib 2 mg plus short GCs treatment in comparison to placebo plus short GCs treatment at week 24.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients - of baricitinib 4 mg plus short GCs treatment in comparison to placebo plus short GCs treatment at week 12.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients - of baricitinib 2 mg plus short GCs treatment in comparison to placebo plus short GCs treatment at week 12.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients - of baricitinib 4 mg plus short GCs treatment in comparison baricitinib 2 mg plus short GCs treatment at week 24.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients - of baricitinib 4 mg plus short GCs treatment in comparison baricitinib 2 mg plus short GCs treatment at week 12.
- Exploratory objectives (see synopsis)
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients of baricitinib 4 mg plus short GCs treatment in comparison to placebo plus short GCs treatment at week 36.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients of baricitinib 2 mg plus short GCs treatment in comparison to placebo plus short GCs treatment at week 36.
- To demonstrate the ability to obtain a disease activity [PMR-AS-CRP] lower or equal to 10 without oral GCs (prednisone or prednisolone) in PMR patients of baricitinib 4 mg plus short GCs treatment in comparison baricitinib 2 mg plus short GCs treatment at week 36.
Conditions and MedDRA coding
Polymyalgia Rheumatica (PMR)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10036099 | Polymyalgia rheumatica | 100000004859 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period JADORE-BARI is a multicentre, double-blinded, randomized placebo-controlled trial in 3 parallel groups comparing:
- baricitinib 4 mg (1 tablet Bari 4mg + 1 tablet Placebo 2mg) plus short GCs treatment
- baricitinib 2 mg (1 tablet Placebo 4mg + 1 tablet Bari 2mg) plus short GCs treatment
- placebo (1 tablet Placebo 4mg + 1 tablet Placebo 2mg) plus short GCs treatment
|
Randomised Controlled | Double | [{"id":141360,"code":1,"name":"Subject"},{"id":141357,"code":2,"name":"Investigator"},{"id":141358,"code":5,"name":"Carer"},{"id":141359,"code":3,"name":"Monitor"}] | baricitinib 4 mg: At W0, Patients will be randomly assigned in a 1:1:1 ratio to blinded daily treatment with oral baricitinib 4 mg (1 tablet Bari 4mg + 1 tablet Placebo 2mg) for 12 wekks. At week 12, if PMR-AS ≤10 without GCs, they will receive baricitinib or placebo at the same dosage for 12 weeks and then will stop treatment. baricitinib 2 mg: At W0, Patients will be randomly assigned in a 1:1:1 ratio to blinded daily treatment with oral baricitinib 2 mg (1 tablet Placebo 4mg + 1 tablet Bari 2mg) for 12 weeks. At week 12, if PMR-AS ≤10 without GCs, they will receive baricitinib or placebo at the same dosage for 12 weeks and then will stop treatment. placebo: At W0, Patients will be randomly assigned in a 1:1:1 ratio to blinded daily treatment with oral placebo (1 tablet Placebo 4mg + 1 tablet Placebo 2mg) for 12 weeks. At week 12, if PMR-AS ≤10 without GCs, they will receive baricitinib or placebo at the same dosage for 12 weeks and then will stop treatment. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518385-26-00 | Justification AnD evaluation, in pOlymyalgia RhEumatica, of BARIcitinib versus placebo (JADORE-BARI study) | Centre Hospitalier Regional Et Universitaire De Brest |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- At least 50 years of age.
- Fulfilling ACR/EULAR classification criteria for PMR newly diagnosed or treatment resistant.
- No GCs or GCs <15 mg/day since at least 15 days prior to planned randomization.
- PMR-AS-CRP >17.
- Absence of other inflammatory arthropathy, connective tissue diseases or vasculitis.
- Able to give informed consent.
- French health insurance holder
Exclusion criteria 15
- Clinical evidence of giant cell arteritis.
- Total bilirubin level (TBL) ≥1.5 x ULN.
- Neutropenia (absolute neutrophil count <1000 cells/uL) (<1.00 x 103/uL or <1.00 GI/L).
- Lymphopenia (lymphocyte count <500 cells/uL) (<0.50 x 103/uL or <0.50 GI/L).
- Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol.
- Uncontrolled high blood pressure or cardiovascular disease.
- High risk of VTE because of a history of VTE (DVT and/or PE) within 12 weeks prior to randomization or a history of recurrent (>1) VTE (counting co-occurring DVT+PE as 1 single event).
- Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
- Planned major surgical procedure during the study or medical history, blood abnormalities or any clinical condition that compromises inclusion.
- 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.
- Treatment by probenecid.
- Alkaline phosphatase (ALP) ≥2 x ULN.
- Current smoker if age >65 years.
- Patient under court protection or protected adults
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is a PMR-AS (CRP) ≤10 (no flare) without steroids at week 24.
Secondary endpoints 9
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Olumiant 2 mg film-coated tablets
PRD4847299 · Product
- Active substance
- Baricitinib
- Substance synonyms
- LY-3009104, INCB-028050
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 2 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA37 — -
- Marketing authorisation
- EU/1/16/1170/008
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with the same commercial drug substance (baricitinib) and unit formula as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
Olumiant 4 mg film-coated tablets
PRD4847307 · Product
- Active substance
- Baricitinib
- Substance synonyms
- LY-3009104, INCB-028050
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 4 mg milligram(s)
- Max total dose
- 4 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA37 — -
- Marketing authorisation
- EU/1/16/1170/016
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- IMP is packaged for clinical trials use. IMP is manufactured with the same commercial drug substance (baricitinib) and unit formula as Olumiant. Drug product and excipients may have different facilities, specifications, methods, shelf-life, and packaging. No commercial debossing on tablets. All still appropriate for clinical trial use.
Placebo 2
tablets containing placebo to match 4 mg baricitinib
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
tablets containing placebo to match 2 mg baricitinib
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Adrien CLARYSSE
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Adrien CLARYSSE
Locations
1 EU/EEA country · 22 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 140 | 22 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Rhumatologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centre Hospitalier Universitaire De Dijon
Rhumatologie, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier De Cholet
Rhumatologie, 1 Rue De Marengo, 49300, Cholet
University Of Bordeaux
Rhumatologie, 1 Place Amelie Raba Leon, Cs 91286, Bordeaux Cedex
Assistance Publique Hopitaux De Paris
Rhumatologie, 43 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Nice
Rhumatologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Caen Normandie
Rhumatologie, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier Des Pays De Morlaix
Rhumatologie, 15 Rue De Kersaint Gilly, Bp 97237, Morlaix
Centre Hospitalier Regional Universitaire De Tours
Rhumatologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Paris
Rhumatologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
University Hospital Of Clermont-Ferrand
Rhumatologie, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Le Mans
Rhumatologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Les Hopitaux Universitaires De Strasbourg
Rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Paris
Rhumatologie, 78 Rue Du General Leclerc, 94270, Le Kremlin-Bicetre
Centre Hospitalier Universitaire De Toulouse
Rhumatologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
CHU Besancon
Centre d'Investigation Clinique, 2 Place Saint Jacques, Cs 51804, Besancon Cedex
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Médecine interne - Rhumatologie, Avenue Des Tamaris, 13100, Aix En Provence
Centre Hospitalier Regional Et Universitaire De Brest
Rhumatologie, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier D'Arras
Rhumatologie, 3 Boulevard Georges Besnier, 62000, Arras
Centre Hospitalier Universitaire Reims
Rhumatologie, 45 Rue Cognacq Jay, 51100, Reims
Centre Hospitalier Regional De Marseille
Rhumatologie, 270 Boulevard De Sainte Marguerite, 13009, Marseille
CHU Besancon
Rhumatologie, 3 Boulevard Alexandre Fleming, 25000, Besancon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-12-18 | 2025-12-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocole_2024-518385-26-01 | 1.4 |
| Protocol (for publication) | D1_Protocole_2024-518385-26-01_Tracked changes | 1.4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults FR_2024-518385-26-01 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocole synopsis_ENG 2024-518385-26-01 | 1.4 |
| Synopsis of the protocol (for publication) | D1_Protocole synopsis_FR 2024-518385-26-01 | 1.4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-20 | France | Acceptable 2025-10-03
|
2025-10-07 |