BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

Last updated: November 28, 2023
Sponsor: University Hospital, Brest
Overall Status: Completed

Phase

2

Condition

Polymyalgia Rheumatica (Pmr)

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

Placebos

Baricitinib

Clinical Study ID

NCT04027101
BACHELOR (29BRC18.0144)
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 diseasesnot 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 cervicalcarcinoma, basal cell or squamous epithelial skin cancer resected with no evidence ofrecurrence or metastatic disease).
  • Current active uncontrolled infection
  • Detailed exclusion criteria related to prior or concomitant therapy, general safetyand laboratory data are reported in the protocol

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: Placebos
Phase: 2
Study Start date:
December 01, 2020
Estimated Completion Date:
August 30, 2023

Connect with a study center

  • Chu Bordeaux

    Bordeaux, 33076
    France

    Site Not Available

  • CHU Brest

    Brest, 29200
    France

    Site Not Available

  • CH Le Mans

    Le Mans,
    France

    Site Not Available

  • CHU Montpellier

    Montpellier,
    France

    Site Not Available

  • Ch Morlaix

    Morlaix, 29672
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CHU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Chu Tours

    Tours, 37044
    France

    Site Not Available

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