BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
NCT ID: NCT04027101
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2020-12-01
2023-08-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group
Oral baricitinib 4mg/day for 12 weeks. Then, at week 12, if PMR-AS≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS ≤10, the patients will not receive any treatment until W24 At W24, if PMR-AS\>10, they will receive GCs according to the PMR-AS (PMR-AS\<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS\> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1 mg every week) or increased according to PMR-AS (PMR-AS \< 10: decrease, PMR-AS \> 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) according to investigator's opinion.
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
Control group
Oral placebo every day during 3 months (W12). Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS ≤10, the patients do not receive any treatment until a flare. If PMR-AS\>10, they will receive GCs according to the PMR-AS (PMR-AS\<10: no GCs, PMR-AS between 10-20: 10mg/day, PMR-AS between 21-30: GCs at 15mg/d and if PMR-AS\> 30: 20mg/d or more according to investigator's opinion). Dosage of GCs will be decreased (1mg every week) or increased according to PMR-AS (PMR-AS \< 10: decrease, PMR-AS \> 20 increase, 10 ≤ PMR-AS ≤ 20: stable dose) and according to investigator's opinion.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
University Hospital, Brest
OTHER
Responsible Party
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Locations
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Chu Bordeaux
Bordeaux, , France
CHU Brest
Brest, , France
CH Le Mans
Le Mans, , France
CHU Montpellier
Montpellier, , France
Ch Morlaix
Morlaix, , France
CHU Nice
Nice, , France
CHU Strasbourg
Strasbourg, , France
Chu Tours
Tours, , France
Countries
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References
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Saraux A, Carvajal Alegria G, Dernis E, Roux C, Richez C, Tison A, Quere B, Jousse-Joulin S, Guellec D, Marhadour T, Kervarrec P, Cornec D, Le Henaff C, Lesven S, Nowak E, Souki A, Devauchelle-Pensec V. Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Rheumatol. 2025 Apr;7(4):e233-e242. doi: 10.1016/S2665-9913(24)00270-4. Epub 2025 Jan 13.
Other Identifiers
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BACHELOR (29BRC18.0144)
Identifier Type: -
Identifier Source: org_study_id