Polymyalgia Rheumatic (PMR) Clinical Trial
— BACHELOROfficial title:
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)
| Verified date | November 2023 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | August 30, 2023 |
| Est. primary completion date | August 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | 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 exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest | Eli Lilly and Company |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Following of the Polymyalgia Rheumatica Activity score | 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) | 12 weeks | |
| Secondary | Following of the Polymyalgia Rheumatica Activity score | 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) | 36 weeks | |
| Secondary | Emergence of adverse events (Safety and tolerability) | The safety is evaluated with the adverse events in both arms | 36 weeks | |
| Secondary | Following of the cumulative dosages of Glucocorticoids | dosages of GCs | 36 weeks | |
| Secondary | ultrasound of synovitis and tenosynovitis | ultrasound scoring of synovitis and tenosynovitis | 24 weeks | |
| Secondary | Level of biological markers | Level of biological markers and cell subpopulations (Interleukin, cytokines, immune cells) by result of blood test is evaluated. | 24 weeks | |
| Secondary | Following of the quality of life | 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]. | 36 weeks | |
| Secondary | Following of the quality of life | The Hospital Anxiety and the Depression scale (HAD) is used to evaluate the quality of life.
The HAD scale has 14 items rated from 0 to 3 with 7 questions relate to anxiety and 7 others to the depressive dimension. |
36 weeks | |
| Secondary | Following of the quality of life | 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). | 36 weeks |