Baricitinib in Patients With Relapsing or naïve Dermatomyositis

Recruiting Phase 3 Interventional Study
Dermatomyositis
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 64
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 n…
Trial Locations
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Eligibility Criteria
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 cors…
Contacts

YVES ALLENBACH, MD, PhD

00 33 1 42 16 10 68

yves.allenbach@aphp.fr

CONTACT

SARRA POCHON

00 33 1 42 16 75 74

sarra.pochon@aphp.fr

CONTACT