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Trial record 47 of 62 for:    Baricitinib

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR)

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ClinicalTrials.gov Identifier: NCT04027101
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
University Hospital, Brest

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
Polymyalgia Rheumatic (PMR) Drug: Baricitinib Drug: Placebos Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter double blinded randomized placebo controlled trial
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027101


Contacts
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Contact: Alain Saraux, PUPH 0298347264 ext +33 alain.saraux@chu-brest.fr

Locations
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France
Chu Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Christophe RICHEZ, PUPH       christophe.richez@chu-bordeaux.fr   
CHU Brest Not yet recruiting
Brest, France, 29200
Contact: Alain SARAUX, PUPH       alain.saraux@chu-brest.fr   
Ch Morlaix Not yet recruiting
Morlaix, France, 29672
Contact: Catherine LE HENAFF       clehenaff@ch-morlaix.fr   
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Brest
Eli Lilly and Company

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04027101     History of Changes
Other Study ID Numbers: BACHELOR (29BRC18.0144)
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Rheumatic Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Muscular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases