BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Overview

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.

Full Title of Study: “BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 30, 2023

Interventions

  • 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
  • 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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Following of the Polymyalgia Rheumatica Activity score
    • Time Frame: 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 Measures

  • Following of the Polymyalgia Rheumatica Activity score
    • Time Frame: 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)
    • Time Frame: 36 weeks
    • The safety is evaluated with the adverse events in both arms
  • Following of the cumulative dosages of Glucocorticoids
    • Time Frame: 36 weeks
    • dosages of GCs
  • ultrasound of synovitis and tenosynovitis
    • Time Frame: 24 weeks
    • ultrasound scoring of synovitis and tenosynovitis
  • Level of biological markers
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Brest
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor

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