Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01939132
Status:
UNKNOWN
Last Update Posted:
2013-09-11
First Post:
2013-09-03
Brief Title:
Protocol for HP Acthar Gel in Moderately to Severely Active Psoriatic Arthritis
Sponsor:
Fiechtner Justus J MD PC
Organization:
Fiechtner Justus J MD PC
Study Overview
Official Title:
Title of Study A Single-Site Investigator Initiated Open-Label Trial of HP Acthar Gel Repository Corticotropin Injection an Adrenocorticotropic Hormone ACTH Analogue in Subjects With Moderately to Severely Active Psoriatic Arthritis PsA
Status:
UNKNOWN
Status Verified Date:
2013-09
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints tendon sheaths entheses and the axial skeleton as well as skin and nails This is an open-label trial with HP Acthar Gel 80 units1mL Subcutaneous injection administered twice weekly To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks including American College of Rheumatology 20Clinical Disease Activity Index Disease Activity Index 28 Dactylitis and adverse events
Detailed Description:
The subjects in this study will be adult men and women ages 18-75 years of age at the time of screening with chronic moderately-to-severely active PsA and meeting ACR criteria
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