Status:
COMPLETED
Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Mallinckrodt
Conditions:
Dermatomyositis
Juvenile Dermatomyositis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 amyopathi...
Detailed Description
Adult and juvenile dermatomyositis (DM) are systemic immune-mediated inflammatory diseases most commonly affecting the skin and musculoskeletal system. Amyopathic dermatomyositis is a subtype of derma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02245841
Start Date
June 15 2015
End Date
July 14 2021
Last Update
June 11 2024
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195