BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica

University Hospital, Brest34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Polymyalgia Rheumatic (PMR)

Interventions

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (8)

Chu Bordeaux

Bordeaux, France

CHU Brest

Brest, France

CH Le Mans

Le Mans, France

CHU Montpellier

Montpellier, France

Outcomes

Primary Outcomes

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)

Time frame: 12 weeks

Secondary Outcomes

Following of the Polymyalgia Rheumatica Activity score

Time frame: 36 weeks

Emergence of adverse events (Safety and tolerability)

The safety is evaluated with the adverse events in both arms

Time frame: 36 weeks

Following of the cumulative dosages of Glucocorticoids

dosages of GCs

Time frame: 36 weeks

ultrasound of synovitis and tenosynovitis

ultrasound scoring of synovitis and tenosynovitis

Time frame: 24 weeks

Level of biological markers

Data from ClinicalTrials.gov

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