BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (NCT04027101) | Clinical Trial Compass
CompletedPhase 2
BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica
France34 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Following of the Polymyalgia Rheumatica Activity score