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Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis

NCT02245841 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-06-11

Study results available
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Summary

This study will assess the safety and efficacy of H.P. Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis, juvenile dermatomyositis, and amyopathic dermatomyositis. Our hypothesis is that H.P. Acthar gel will be both safe and effective for such patients.

Conditions

  • Dermatomyositis
  • Juvenile Dermatomyositis

Interventions

DRUG

H.P. Acthar Gel

80 U (1 mL) of H.P. Acthar gel via subcutaneous injection twice weekly for 24 weeks

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Anthony P Fernandez, MD, PhD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-15
Primary Completion
2021-07-14
Completion
2021-07-14

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245841 on ClinicalTrials.gov