A Phase 3 interventional study of Baricitinib 4 MG Oral Tablet and Baricitinib 2 MG Oral Tablet in Polymyalgia Rheumatica (PMR), sponsored by University Hospital, Brest. Recruiting at 23 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University Hospital, Brest · Phase 3, Interventional, and Treatment
Polymyalgia rheumatic (PMR) is an inflammatory rheumatic disease affecting the elderly. The diagnosis is based on established ACR/EULAR classification criteria.
The activity of the disease is evaluated using the PMR-AS, a disease activity score based on morning stiffness, ability to elevate the upper limbs, physician's global disease assessment and pain assessment measured by the patient using VAS, and the C-reactive protein (CRP) level. The PMR-AS-CRP (PMR-AS) is considered as relevant to define disease activity (low activity \<7; moderate activity 7 to 17; high activity >17), flare (>10), remission (\<1.5), but also to decide if treatment has to be decreased, unchanged or increased (PMR-AS \<10: decrease, PMR-AS >20 increase, 10≤ PMR-AS ≤20: stable dose) [10-12].
Long term low-dose glucocorticoid (GCs) (prednisone or prednisolone started at 12.5 to 25 mg/day progressively tapered) is the mainstay of the treatment. But comorbidities in PMR are due to GCs and 30% of the patients underwent a relapse when tapering GCs.
Today, the physicians do not know what is the best duration and the best dosage of GCs. The international recommendation suggests to start prednisone at a dose between 12.5 to 25 mg, to be at 10 mg at 1 or 2 months, and then to decrease slowly. The treatment is generally ordered for 6-18 months but it is possible to try a shorter treatment duration when patients have been previously treated with GCs or in case of comorbidities.
The TENOR study, a phase 2 study, demonstrated efficacy of tocilizumab as first line treatment in PMR and its ability to spare GCs. The Semaphore study confirmed the usefulness of tocilizumab in corticodependent forms and demonstrated its efficacy. Another IL-6 inhibitor, sarilumab was authorized for the treatment for polymyalgia rheumatic in adult patients with inadequate response to corticosteroid or relapsing disease but is not reimbursed in France.
Baricitinib is an oral selective JAK inhibitor of JAK1 and JAK2 with a short half-life. There are two dosages available (i.e., 2-mg and 4-mg) which can help conduct a simple dose tapering. Administration of baricitinib resulted in a rapid dose dependent inhibition of IL-6 induced STAT3 phosphorylation. An evaluation could be made using the PMR-AS with and without imputation to minimize the effect of baricitinib on CRP by anti-IL-6 effect.
Preliminary results of the BACHELOR study (34 patients treated with baricitinib or placebo) suggested a great efficacy of baricitinib in early PMR without steroids.
It could be a treatment of PMR, with low dose or no steroids only during the first month, to minimize the adverse events of steroids. JAK inhibitors have been reevaluated by EMA, the Oral Surveillance study suggesting that tofacitinib (Xeljanz®) increases the risk of major cardiovascular problems, cancer, VTE, serious infections and death due to any cause when compared with medicines belonging to the class of TNF-alpha inhibitors. EMA has concluded that these safety findings apply to all approved uses of JAK inhibitors in chronic inflammatory disorders. Nevertheless, the risk was not increased during the first months of treatment in all studies and a short treatment could have lower risks than steroids.
As no suitable treatment alternatives are available, excepted GCs which increase the vascular risk and osteoporosis, short treatment by jak inhibitor could be a relevant alternative treatment of PMR. Indeed, the physicians do not have any disease modifying drug (excepted anti IL6 off-label) in treatment of PMR. So, GCs are used for more than one year in the treatment of PMR. Baricitinib, used only 6 months demonstrated its ability to cure early PMR without steroids. It could be an alternative to steroid when physicians consider that ratio benefit/risk is better with a 6 months treatment by baricitininib than >one year by steroids.
Our goal is now to demonstrate in a large cohort the ability of a 6-month treatment with baricitinib in comparison to placebo to decrease glucocorticoids and then to maintain low disease activity without corticosteroids in PMR and a good safety profile.
Due to the possible lower risk of 2 mg than 4 mg of baricitinib, but probably a lower efficacy, the investigators plan to compare both baricitinib (4 mg and 2 mg) to placebo. The study will be conducted in France.
68 studies on the registry are indexed under Polymyalgia Rheumatica; 22 are open to participants now.
This study's planned enrollment of 140 is above the median of 66 across 39 interventional studies indexed under Polymyalgia Rheumatica.
Browse Polymyalgia Rheumatica studies →University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral baricitinib 4 mg for 12 weeks; Oral GCs prescribed at baseline Then, at week 12, if PMR-AS ≤10, patients will receive baricitinib 4 mg for 12 weeks. If PMR-AS \>10, they will receive GCs according to the PMR-AS. 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 4 MG Oral Tablet · Drug: Placebo 2 mg
Oral baricitinib 2 mg for 12 weeks; Oral GCs prescribed at inclusion Then, at week 12, if PMR-AS ≤10, patients will receive baricitinib 2 mg for 12 weeks. If PMR-AS \>10, they will receive GCs according to the PMR-AS. 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 2 MG Oral Tablet · Drug: Placebo 4 mg
Oral placebo for 12 weeks; Oral GCs at inclusion. Then, at week 12, if PMR-AS ≤10, placebo for 12 weeks. If PMR-AS \>10, they will receive GCs according to the PMR-AS. 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) and according to investigator's opinion.
Drug: Placebo 4 mg · Drug: Placebo 2 mg
Patient will take a tablet of 4 mg/d during 12 weeks and then 4 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12.
Patient will take a tablet of 2 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12.
Patient will take a tablet of placebo for 12 weeks and then placebo during 12 weeks if the patient achieves PMR-AS ≤ 10 at week 12.
Patient will take a tablet of placebo for 12 weeks and then placebo during 12 weeks if the patient achieves PMR-AS ≤ 10 at week 12.
Following of the Polymyalgia Rheumatica Activity score
Polymyalgia Rheumatica Activity Score (PMR-AS) ≤10 (no flare) without steroids at week 24. The Polymyalgia Rheumatica Activity Score is calculated by combining several parameters (patient's pain assessment (using a visual analogue scale) + physician's global assessment of the disease (using a visual analogue scale)+ morning stiffness + C-Reactive Protein level). If PMR-AS ≤ 1,5 means remission of the disease. If PMR-AS \< 7 means inactive activity of the disease. If 7 \<PMR-AS \< 17 means low activity of the disease. If PMR-AS \> 17 means high activity of the disease.
Time frame: From week 0 to week 24
Following of the Polymyalgia Rheumatica Activity score
Polymyalgia Rheumatica Activity score ≤10 (no flare) without steroids at week 12. The Polymyalgia Rheumatica Activity Score is calculated by combining several parameters (patient's pain assessment (using a visual analogue scale) + physician's global assessment of the disease (using a visual analogue scale)+ morning stiffness + C-Reactive Protein level). If PMR-AS ≤ 1,5 means remission of the disease. If PMR-AS \< 7 means inactive activity of the disease. If 7 \<PMR-AS \< 17 means low activity of the disease. If PMR-AS \> 17 means high activity of the disease.
Time frame: From week 0 to week 12
Following of the Polymyalgia Rheumatica Activity score
Polymyalgia Rheumatica Activity score ≤10 (no flare) without steroids at week 36. The Polymyalgia Rheumatica Activity Score is calculated by combining several parameters (patient's pain assessment (using a visual analogue scale) + physician's global assessment of the disease (using a visual analogue scale)+ morning stiffness + C-Reactive Protein level). If PMR-AS ≤ 1,5 means remission of the disease. If PMR-AS \< 7 means inactive activity of the disease. If 7 \<PMR-AS \< 17 means low activity of the disease. If PMR-AS \> 17 means high activity of the disease.
Time frame: From week 0 to week 36
Following of the Polymyalgia Rheumatica Activity score
Absence of flare according to the investigator at week 36.
Time frame: From week 0 to week 36
Plan to share: Yes — All collected data that underlie results in a publication.
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Studies of the drug tested here: Baricitinib