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Completed

NCT Number: NCT04027101

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

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.

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Key information

Conditions

Polymyalgia Rheumatic (PMR)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baricitinib

Drug

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

Placebos

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. Emergence of adverse events (Safety and tolerability)

    Time frame: 36 weeks

    The safety is evaluated with the adverse events in both arms

  3. Following of the cumulative dosages of Glucocorticoids

    Time frame: 36 weeks

    dosages of GCs

  4. ultrasound of synovitis and tenosynovitis

    Time frame: 24 weeks

    ultrasound scoring of synovitis and tenosynovitis

  5. 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.

  6. 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].

  7. 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.

  8. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

Acronym: BACHELOR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2019
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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