Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations o… (NCT02245841) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
United States19 participantsStarted 2015-06-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
*…
What they're measuring
1
Change From Baseline in Cutaneous Dermatomyositis at 6 Months
Timeframe: 6 months
2
Change in Physician's Global Assessment (PGA) Visual Acuity Score From Baseline to 6 Months