BACHELOR: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental group 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. |
Drug: Baricitinib
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
|
| Placebo Comparator: Control group 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. |
Drug: Placebos
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Following of the cumulative dosages of Glucocorticoids [36 weeks]
dosages of GCs
- 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 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].
- Following of the quality of life [36 weeks]
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.
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
At least 50 years of age
-
Fulfilling ACR/EULAR criteria for PMR
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Disease duration ≤6 months
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No oral or parenteral steroid since ≥ 2 weeks prior to randomization
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PMR-AS >17
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Absence of connective tissue diseases or vasculitis
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Able to give informed consent
Exclusion Criteria:
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Clinical symptoms of giant cell arteritis
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Uncontrolled high blood pressure or cardiovascular disease
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Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
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Planned major surgical procedure during the study.
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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).
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Current active uncontrolled infection
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Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Bordeaux | Bordeaux | France | 33076 | |
| 2 | CHU Brest | Brest | France | 29200 | |
| 3 | CH Le Mans | Le Mans | France | ||
| 4 | CHU Montpellier | Montpellier | France | ||
| 5 | Ch Morlaix | Morlaix | France | 29672 | |
| 6 | CHU Nice | Nice | France | ||
| 7 | CHU Strasbourg | Strasbourg | France | ||
| 8 | Chu Tours | Tours | France | 37044 |
Sponsors and Collaborators
- University Hospital, Brest
- Eli Lilly and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BACHELOR (29BRC18.0144)