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Polymyalgia Rheumatic (PMR)Phase 2BACHELORNCT04027101

BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

A Phase 2 study testing Baricitinib in people with Polymyalgia Rheumatic (PMR), run by University Hospital, Brest at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Polymyalgia Rheumatic (PMR)
What is being tested?
Baricitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
8 sitesFrance
Study dates
1 Dec 2020to 30 Aug 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites

  • Chu Bordeaux

    Bordeaux, 33076

  • CHU Brest

    Brest, 29200

  • CH Le Mans

    Le Mans

  • CHU Montpellier

    Montpellier

  • Ch Morlaix

    Morlaix, 29672

  • CHU Nice

    Nice

  • CHU Strasbourg

    Strasbourg

  • Chu Tours

    Tours, 37044

Other trials in France

About this study

Official title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)

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.

Being tested
Baricitinib, Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BaricitinibDrug

    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

  • PlacebosDrug

    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

Study groups in NCT04027101
Study groupRoleWhat they receive
Experimental groupExperimentalOral 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.
Receives: Drug: Baricitinib
Control groupPlacebo comparatorOral 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.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Following of the Polymyalgia Rheumatica Activity score

    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)

    Measured: 12 weeks

Secondary outcomes (8)

  1. Following of the Polymyalgia Rheumatica Activity score

    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)

    Measured: 36 weeks

  2. Emergence of adverse events (Safety and tolerability)

    The safety is evaluated with the adverse events in both arms

    Measured: 36 weeks

  3. Following of the cumulative dosages of Glucocorticoids

    dosages of GCs

    Measured: 36 weeks

  4. ultrasound of synovitis and tenosynovitis

    ultrasound scoring of synovitis and tenosynovitis

    Measured: 24 weeks

  5. Level of biological markers

    Level of biological markers and cell subpopulations (Interleukin, cytokines, immune cells) by result of blood test is evaluated.

    Measured: 24 weeks

  6. Following of the quality of life

    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].

    Measured: 36 weeks

  7. Following of the quality of life

    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.

    Measured: 36 weeks

  8. Following of the quality of life

    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).

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start1 Dec 2020
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multicenter double blinded randomized placebo controlled trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04027101
Sponsor's protocol ID
BACHELOR (29BRC18.0144)
Acronym
BACHELOR
Status last verified
Nov 2023
First submitted
16 May 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Publications

  • Saraux A, Carvajal Alegria G, Dernis E, Roux C, Richez C, Tison A, Quere B, Jousse-Joulin S, Guellec D, Marhadour T, Kervarrec P, Cornec D, Le Henaff C, Lesven S, Nowak E, Souki A, Devauchelle-Pensec V. Baricitinib in early polymyalgia rheumatica (BACHELOR): a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Rheumatol. 2025 Apr;7(4):e233-e242. doi: 10.1016/S2665-9913(24)00270-4. Epub 2025 Jan 13.

    PubMed 39818228

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Baricitinib in people with Polymyalgia Rheumatic (PMR), run by University Hospital, Brest at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Following of the Polymyalgia Rheumatica Activity score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027101, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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