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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 11 August 2020
Main ID:  JPRN-jRCTs031200005
Date of registration: 10/04/2020
Prospective Registration: Yes
Primary sponsor: Okiyama Naoko
Public title: Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis
Scientific title: Investigation on the safety and utility of apremilast for the treatment of refractory rash in patients with dermatomyositis - ACDM
Date of first enrolment: 30/04/2020
Target sample size: 5
Recruitment status: Not Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs031200005
Study type:  Interventional
Study design:  single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  1-2
Countries of recruitment
Japan
Contacts
Name: Naoko    Okiyama
Address:  2-1-1 Amakubo, Tsukuba, Ibaraki 305-7585 Ibaraki Japan
Telephone: +81-29-853-3128
Email: naoko.okiyama@md.tsukuba.ac.jp
Affiliation:  University of Tsukuba Hospital
Name: Naoko    Okiyama
Address:  2-1-1 Amakubo, Tsukuba, Ibaraki 305-8575 Ibaraki Japan
Telephone: +81-29-853-3128
Email: naoko.okiyama@md.tsukuba.ac.jp
Affiliation:  University of Tsukuba Hospital
Key inclusion & exclusion 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: 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


Age minimum: >= 20age old
Age maximum: < 80age old
Gender: Both
Health Condition(s) or Problem(s) studied
D003882
Dermatomyositis
Collagen disease, inflammatory myopathy, cutaneous manifestation
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
Primary Outcome(s)
Safety
Secondary Outcome(s)
CDASI, serum profile of cytokines, VAS for itching, DLQI
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 27/02/2020
Contact:
t-credo.adm@un.tsukuba.ac.jp
Tsukuba University Clinical Research Review Board
+81-29-853-3914
t-credo.adm@un.tsukuba.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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