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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02245841
• Date of registration: 11/09/2014
• Prospective Registration: Yes
• Primary sponsor: The Cleveland Clinic
• Public title: Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis Acthar Gel
• Scientific title: Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
• Date of first enrolment: June 15, 2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02245841
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Anthony P Fernandez, MD, PhD
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must be 18 years of age or older with refractory cutaneous symptoms related to either
classic dermatomyositis (CD), juvenile dermatomyositis (JD), or amyopathic
dermatomyositis(AD). Diagnosis will be based on either Bohan and Peter criteria (CD
and JD) or Sontheimer's criteria (AD)

- Must have had a skin biopsy with histologic features consistent with dermatomyositis
and current cutaneous manifestations consistent with dermatomyositis.

- Although not mandatory, patients with evidence of current or previous active myositis
will be eligible for enrollment. Patients will be considered to have refractory
disease if cutaneous manifestations exist despite treatment with steroids and at least
one steroid-sparing systemic treatment commonly found to be useful in patients with
dermatomyositis. These may include azathioprine, cyclosporine, mycophenolate mofetil,
IVIG, methotrexate, cyclophosphamide, chlorambucil, sirolimus, adalimumab, infliximab
and rituximab.

- Use of topical medications and sunscreen currently and in past will be noted but not
weighed for assessment of refractory cutaneous disease.

Exclusion Criteria:

- Patients with dermatomyositis who have minimal-to-no active cutaneous features (focal
involvement with less than 1% total body surface area involved or minimal modified
CDASI activity score).

- Patients whose cutaneous findings are not consistent with dermatomyositis and/or have
previous biopsy results suggestive of an alternative diagnosis

- Patients with inflammatory myositis other than dermatomyositis, such as polymyositis
or inclusion body myositis.

- Patients with malignancy-associated dermatomyositis

- Patients with clear features of an overlap myositis

- Patients younger than 18 years old

- Patients with acutely active or chronic infections.

- Patients with uncontrolled diabetes, hypertension, cardiovascular, hepatic, or renal
disease

- Pregnant or lactating females.

- Patients with any medical condition that is felt by the primary investigator to place
the patient at unreasonable risk for adverse effects during treatment with H.P.
Acthar.

- Hypersensitivity to H.P. Acthar, any of its components (allergy to pig-derived
proteins)

- Patients with osteoporosis

- Patients who have had surgery within 8 weeks of screening

- Patients with a history of or current gastric ulcers

- Patients taking daily doses of systemic corticosteroids greater than the equivalent of
40mg prednisone.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Dermatomyositis

Dermatomyositis

Intervention(s)

Drug: H.P. Acthar Gel

Primary Outcome(s)

Change from baseline in cutaneous manifestations of dermatomyositis at 1, 3, and 6 months [Time Frame: 6 months]

Secondary Outcome(s)

Change from baseline in patient assessment of dermatomyositis at 1, 3, and 6 months [Time Frame: 6 months]

Secondary ID(s)

14-1015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt