BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
- Registration Number
- NCT04027101
- Lead Sponsor
- University Hospital, Brest
- 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 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Placebos 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. Experimental group Baricitinib 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.
- Primary Outcome Measures
Name Time Method Following of the Polymyalgia Rheumatica Activity score 12 weeks The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS \< 10: decrease, PMR-AS \> 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
- Secondary Outcome Measures
Name Time Method Following of the Polymyalgia Rheumatica Activity score 36 weeks The activity of Polymyalgia Rheumatica is evaluated using the Polymyalgia Rheumatica Activity score (PMR-AS), a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment , Visual Analog Score for patient's pain (VAS), and CRP level. The PMR-AS is considered as relevant to define relapse and remission but also to decide if treatment have to be decreased, unchanged or increased (PMR-AS \< 10: decrease, PMR-AS \> 17 increase to previous dosage, 10 ≤ PMR-AS ≤ 17: stable dose)
Emergence of adverse events (Safety and tolerability) 36 weeks The safety is evaluated with the adverse events in both arms
ultrasound of synovitis and tenosynovitis 24 weeks ultrasound scoring of synovitis and tenosynovitis
Level of biological markers 24 weeks Level of biological markers and cell subpopulations (Interleukin, cytokines, immune cells) by result of blood test is evaluated.
Following of the cumulative dosages of Glucocorticoids 36 weeks dosages of GCs
Following of the quality of life 36 weeks The scale EuroQol 5 dimensions (EDQ5) is used to evaluate the quality of life. The EQ-5D scale is a standardised measure of health status to provide a simple, generic measure of health for clinical and economic appraisal, whih is divided by the EQ-5D descriptive system (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the EQ Visual Analogue scale (EQ VAS). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Trial Locations
- Locations (8)
CHU Montpellier
🇫🇷Montpellier, France
CH Le Mans
🇫🇷Le Mans, France
CHU Strasbourg
🇫🇷Strasbourg, France
CHU Brest
🇫🇷Brest, France
Ch Morlaix
🇫🇷Morlaix, France
Chu Bordeaux
🇫🇷Bordeaux, France
CHU Nice
🇫🇷Nice, France
Chu Tours
🇫🇷Tours, France