Informations générales (source: ClinicalTrials.gov)
Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
août 2022
février 2026
02 septembre 2025
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of
quality of life and possible life-threatening complications.
Treatment is based on high doses of corticosteroids but this exposes patients to adverse
events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages).
Corticosteroids taper is associated with disease relapses. Although there is no evidence
from the literature, clinical practice guidelines recommends the use of DMARDs such as
methotrexate. However, response is not complete and these DMARDS take time to act.
The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus
kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle
repair and force generation.
JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients
(n=4, case series).
Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit
to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to
usual care.
Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to
obtain prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo
in addition to usual care.
BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two
parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.
This is a multicenter trial in different medical departments in hospitals across France
in different regions.
Out- and in patients will be recruited in hospital departments involved in management and
diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:21:44 | Contacter | |||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Pitie-Salpêtrière hospital APHP - 75013 - Paris - France | SARRA POCHON | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult subjects (≥ 18 years old) < 65 years old
- Dermatomyositis defined according to the 239th ENMC criteria either naïve or
non-naïve DM
- Active disease (ACR/EULAR criteria) defined as :
- Manual Muscle Testing (MMT-8) <145/150 and at least two additional abnormal
corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient
global, physician global and extra-muscular disease activity, Health Assessment
Questionnaire Disability Index >0.25, or elevated muscle enzymes.
- Or cutaneous CDASI > 20 and at least two additional abnormal corset
measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global,
physician global and extra-muscular disease activity, Health Assessment
Questionnaire Disability Index >0.25, or elevated muscle enzymes
- for relapsing/non naïve DM patients :
- in case of corticosteroid exposure patient must receive a stable dose < 30 mg/d
prednisone with or without additional immunosuppressive therapy for at least 4
weeks before the baseline visit.
- Stable dose of immunosuppressive therapy for at least 3 months before
- Affiliation to a social security regime
- Written informed consent
- Adult subjects (≥ 18 years old) < 65 years old
- Dermatomyositis defined according to the 239th ENMC criteria either naïve or
non-naïve DM
- Active disease (ACR/EULAR criteria) defined as :
- Manual Muscle Testing (MMT-8) <145/150 and at least two additional abnormal
corset measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient
global, physician global and extra-muscular disease activity, Health Assessment
Questionnaire Disability Index >0.25, or elevated muscle enzymes.
- Or cutaneous CDASI > 20 and at least two additional abnormal corset
measurements (CSM): >3/10 cm on Visual Analogue Scale (VAS) of patient global,
physician global and extra-muscular disease activity, Health Assessment
Questionnaire Disability Index >0.25, or elevated muscle enzymes
- for relapsing/non naïve DM patients :
- in case of corticosteroid exposure patient must receive a stable dose < 30 mg/d
prednisone with or without additional immunosuppressive therapy for at least 4
weeks before the baseline visit.
- Stable dose of immunosuppressive therapy for at least 3 months before
- Affiliation to a social security regime
- Written informed consent
- Life-threatening complications :
- Severe swallowing troubles defined as: food swallowed the wrong way and/or time
to drink a glass of 200 ml water above 30 seconds related to DM.
- Interstitial lung disease related to the DM with one among the following
complications (complications must be related to the ILD): dyspnea NYHA III,
hypoxemia with PaO2≤65 mmHg, and/or DLCOc/Alveolar Volume ≤70% (pulmonary
function test)
- Symptomatic myocarditis o Loss of walking ability
- Patient with deep vein thrombosis/pulmonary embolism or antecedent
- Patient with antecedent of cardiovascular event (myocardial infarction or ischemic
stroke)
- Patient who is current or past long-time smoker
- Pregnant or lactating, or women planning to become pregnant or initiating
breastfeeding
- No effective contraception during the study and one week after for women of
childbearing age
- Renal impairment defined as clearance < 60 ml
- Strong Organic Anion Transporter 3 (OAT3) inhibitors
- Active cancer or history of malignancy
- Active severe infection including active hepatitis
- Evidence of latent tuberculosis (as documented by a positive QuantiFERON-TB Gold
plus test)
- Absolute Neutrophil Count < 1x109 cells/L
- Haemoglobin (Hb) < 8 g/dL
- Severe hepatic impairment attested by FV (coagulation factor)<30%
- Liver insufficiency (Prothrombin time <60%)
- Previous treatment exposure defined as follow : • Rituximab treatment within 6months
before inclusion
- IVIg, or cyclophosphamide infusion within the month before inclusion
- both methotrexate (0.3 mg/kg/w) and azathioprine exposure for at least 3 months
each and at the 0.3 mg/kg/w and 2-3 mg/kg/d dosages respectively with failure
of both (but exposure and/or failure to either of these two drugs alone is not
an exclusion criterion)
- for naïve DM patients only, more than 2 weeks treatment duration with
corticosteroids at the dose of 1 mg/kg/d before the inclusion.
- Hypersensitivity to the active substance (baricitinib) or to any of the excipients
- Contraindication to Methotrexate and/or Azathioprine including hypersensitivity to
the active substances or to any of the excipients
- Conditions affecting the outcomes (Expected poor compliance)
- Severe disease damages: e.g. muscle weakness mainly related to muscle damage such as
fat replacement of muscle) defined as persistent changes in anatomy, physiology,
pathology or function which result from previously active disease and from
complications of therapy or other events (e.g.; muscle atrophy, fatty replacement;
skin scars, poikiloderma ). Severe disease damage is considered when the patient
condition has no or minor ability to improve with the treatment.
- Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic,
renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or
abnormal laboratory values that developed during a qualifying study that, in the
opinion of the investigator, poses an unacceptable risk for the patient's
participation
- Chest imaging (CT scan or radiograph) showing abnormalities not related with the DM
in the last 12 weeks judged by the investigator as clinically significant.
- Participants included in other intervention research involving humans
- Patient under tutorship or guardianship, and incapable to give informed consent