Dermatomyositis Collagen disease, inflammatory myopathy, cutaneous manifestation
Conditions
Interventions
Oral administration of apremilast: Start with 10 mg of oral dose and gradually increase the dose until day 5, 30mg twice a day from day 6 (morning / evening) for a total of 12 weeks
C505730
PDE4 inhibitor
Sponsors
Okiyama Naoko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with a diagnosis of dermatomyositis 2) Patients still having cutaneous disease activity for more than 12 weeks despite of topical steroid 3) Must be 20 - 80 year-old at time of signing the informed consent form 4) Patients who have been fully informed after participating in this study, and make informed consents with sufficient understanding 5) Patients who are outpatient or hospitalized in our hospital
Exclusion criteria
Exclusion criteria: 1) Recieving or planning to recive for 4 months immuno-inhibitory biologic agetns, JAK inhibitors, or cancer chmotheraphy 2) Recieving or planning to recive for 4 months CYP3A4 inducers 3) Pregnant or women who do not agree to contraception during the study periodlactating women 4) Lactating woman 5) Haveing severe renal dysfunction (creatinine clearance < 30 ml/min) 6) Haveing active infectional disease 7) Patients who the investigators assess to unsuitable as subjects for the study, including patients with history of hypersensitivity to the component
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| CDASI, serum profile of cytokines, VAS for itching, DLQI | — |
Contacts
Public ContactNaoko Okiyama
University of Tsukuba Hospital
Outcome results
None listed