polymyalgia rheumatica MedDRA version: 21.0 Level: PT Classification code 10036099 Term: Polymyalgia rheumatica System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: baricitinib
Product Name: OLUMIANT
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
CHRU BREST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 34
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the ability of baricitinib in comparison to placebo to obtain a disease activity [PMR-AS(CRP)] lower or equal to 10 without oral GCs (prednisone or prednisolone) at week 12 in early PMR patients.;Secondary Objective: To evaluate in both arm: - Ability of baricitinib (4 mg by day for 12 weeks and then 2 mg for 12 weeks) to treat PMR without any dosage of steroids - Safety profile of baricitinib in PMR - PMR-AS(CRP) in baricitinib arm versus placebo - PMR-AS using ESR, imputed CRP, and without CRP - Cost of baricitinib arm in comparison to placebo and GCs - Cumulative dose of GCs in baricitinib arm versus placebo - Evaluation of synovitis and tenosynovitis in shoulders and hips using ultrasound in mode B and Doppler - Proportion of patients with PMR-AS = 1.5 (remission) or PMR-AS > 1.5 (non-remission) at each visit - Proportion of patients with PMR-AS =7 (inactive) 7 17 (high activity) at each visit - Patients with PMR-AS 20 (indication for therapeutic change) at each visit - Biological markers and cells subpopulations -quality of life;Primary end point(s): at week 12, is a PMR-AS (CRP) =10 (no flare) without steroids.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In both arms - PMR-AS(CRP) at inclusion, week 2, 4, 8, 12, 16, 20 24, 28, 36 (i.e. at each visit) - PMR-AS using ESR, imputed CRP and PMR-AS without CRP at each visit - Proportion of patients with PMR-AS = 1.5 (remission) or PMR-AS > 1.5 (non-remission) at each visit - Proportion of patients with PMR-AS =7 (inactive) 7 17 (high activity) at each visit - Patients with PMR-AS 20 (indication for therapeutic change) at each visit - Adverse events following SOC classification - Cost of baricitinib - Cumulative dose of GCs at W24 and W36- Percentage of patients free of GCs and dose of GCs at W12, W20, W24 and W36 - Ultrasound Scoring of synovitis and tenosynovitis (mode B and Doppler) at inclusion and W12 and W24 - Level of biological markers and cell subpopulations in baricitinib and placebo arms: cytokines, immune cells, CRP at inclusion, W12, W24 - Quality of life (SF-36, HAQ-DI, EQ5D) at inclusion, W12, 24 and 36;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Countries
France
Outcome results
None listed