Clinical trial NCT04027101: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
Official title: BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polymyalgia Rheumatic (PMR)
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2019-07-19
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multicenter double blinded randomized placebo controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Following of the Polymyalgia Rheumatica Activity score
timeFrame: 12 weeks
Secondary outcomes:
measure: Following of the Polymyalgia Rheumatica Activity score
timeFrame: 36 weeks
measure: Emergence of adverse events (Safety and tolerability)
timeFrame: 36 weeks
measure: Following of the cumulative dosages of Glucocorticoids
timeFrame: 36 weeks
measure: ultrasound of synovitis and tenosynovitis
timeFrame: 24 weeks
measure: Level of biological markers
timeFrame: 24 weeks
measure: Following of the quality of life
timeFrame: 36 weeks
measure: Following of the quality of life
timeFrame: 36 weeks
measure: Following of the quality of life
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Le Mans
country: France
facility: CH Le Mans
city: Montpellier
country: France
facility: CHU Montpellier
city: Morlaix
country: France
facility: Ch Morlaix
city: Nice
country: France
facility: CHU Nice
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: Chu Tours
Study officials:
References: