Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02245841
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2014-09-11
Brief Title:
Efficacy and Safety of HP Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Efficacy and Safety of HP Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Acthar Gel
Brief Summary:
This study will assess the safety and efficacy of HP Acthar gel for treating the cutaneous manifestations in patients with refractory classic dermatomyositis juvenile dermatomyositis and amyopathic dermatomyositis Our hypothesis is that HP Acthar gel will be both safe and effective for such patients
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 dermatomyositis that affects only the skin and lacks the characteristic muscle involvement Treatment of these conditions in particular the cutaneous manifestations is challenging and currently no universally effective single treatment exists Many patients have cutaneous manifestations that are refractory to numerous medications
HP Acthar gel adrenocorticotropic hormone gel received FDA approval for treatment of a variety of diseases including dermatomyositis in 1952 Despite this there is a paucity of clinical data concerning the efficacy of HP Acthar gel for treating dermatomyositis Recently a small retrospective case series describing significant improvement in both cutaneous and musculoskeletal symptoms in 5 patients with refractory dermatomyositis treated with HP Acthar gel was reported and has resulted in renewed interest in use of this medication in dermatomyositis patient reference below The proposed efficacy of HP Acthar gel has been attributed to its unique ability to induce production of endogenous cortisol corticosterone aldosterone and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses
HP Acthar gel adrenocorticotropic hormone gel received FDA approval for treatment of a variety of diseases including dermatomyositis in 1952 Despite this there is a paucity of clinical data concerning the efficacy of HP Acthar gel for treating dermatomyositis Recently a small retrospective case series describing significant improvement in both cutaneous and musculoskeletal symptoms in 5 patients with refractory dermatomyositis treated with HP Acthar gel was reported and has resulted in renewed interest in use of this medication in dermatomyositis patient reference below The proposed efficacy of HP Acthar gel has been attributed to its unique ability to induce production of endogenous cortisol corticosterone aldosterone and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None