Polymyalgia Rheumatic (PMR)
Conditions
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.
Interventions
DRUGBaricitinib
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
DRUGPlacebos
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
Sponsors
Eli Lilly and Company
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a multicenter double blinded randomized placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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 * Able to give informed consent
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Emergence of adverse events (Safety and tolerability) | 36 weeks | The safety is evaluated with the adverse events in both arms |
| Following of the cumulative dosages of Glucocorticoids | 36 weeks | dosages of GCs |
| 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) |
| 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 quality of life | 36 weeks | The Short Form 36 (SF36) is used to evaluate the quality of life. The SF36 scale includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality \[energy / fatigue\]. |
| ultrasound of synovitis and tenosynovitis | 24 weeks | ultrasound scoring of synovitis and tenosynovitis |
Countries
France
Outcome results
None listed