BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 2

Conditions: Polymyalgia Rheumatic (PMR)

Treatments: Drug: Placebos; Drug: Baricitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04027101

BACHELOR (29BRC18.0144)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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.

Treatment:

Drug: Baricitinib

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos