Status:
COMPLETED
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Polymyalgia Rheumatic (PMR)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04027101
Start Date
December 1 2020
End Date
August 30 2023
Last Update
November 29 2023
Active Locations (8)
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1
Chu Bordeaux
Bordeaux, France, 33076
2
CHU Brest
Brest, France, 29200
3
CH Le Mans
Le Mans, France
4
CHU Montpellier
Montpellier, France