BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

NCT04027101 | Completed Phase 2 DMC

• 1 other identifier: BACHELOR (29BRC18.0144)
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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.

Conditions

Polymyalgia Rheumatic (PMR)

Outcome Measures

Primary Outcomes (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)

  12 weeks

Secondary Outcomes (8)

• Following of the Polymyalgia Rheumatica Activity score

  36 weeks

• Emergence of adverse events (Safety and tolerability)

  36 weeks

• Following of the cumulative dosages of Glucocorticoids

  36 weeks

• ultrasound of synovitis and tenosynovitis

  24 weeks

• Level of biological markers

  24 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

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

Experimental group

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

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead
• Eli Lilly and Company: collaborator

Study Sites (8)

Chu Bordeaux

Bordeaux, 33076, France

Location

CHU Brest

Brest, 29200, France

Location

CH Le Mans

Le Mans, France

Location

CHU Montpellier

Montpellier, France

Location

Ch Morlaix

Morlaix, 29672, France

Location

CHU Nice

Nice, France

Location

CHU Strasbourg

Strasbourg, France

Location

Chu Tours

Tours, 37044, France

Location

Related Publications (1)

• 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.

  PMID: 39818228 DERIVED

MeSH Terms

Interventions

baricitinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter double blinded randomized placebo controlled trial

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: July 19, 2019
• Study Start: December 1, 2020
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FR (8)