Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis

JRCT ID: jRCTs031200005

Registered date:10/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dermatomyositis
• Date of first enrollment: 30/04/2020
• Target sample size: 5
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: CDASI, serum profile of cytokines, VAS for itching, DLQI

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Okiyama Naoko