Protocol for H.P. Acthar Gel in Moderately to Severely Active Psoriatic Arthritis
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 H.P. Acthar Gel (80 units/1mL) Subcutaneous injection administered twice weekly. To evaluate the signs and symptoms of psoriatic arthritis after 12 weeks, including American College of Rheumatology 20,Clinical Disease Activity Index, Disease Activity Index 28, Dactylitis and adverse events.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Title of Study: A Single-Site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection) an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Psoriatic Arthritis (PsA)|
- ACR20 (American College of Rheumatology 20) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To evaluate the efficacy of H.P. Acthar Gel given subcutaneously twice weekly on the signs and symptoms of psoriatic arthritis after 12 weeks of administration.
ACR20 (American College of Rheumatology 20) at week 12
- Adverse Events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]Adverse events and vital signs will be measured and monitored for 24 weeks.
- Clinical Disease Activity Index (CDAI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Disease Activity Index 28 (DAS28) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Dactylitis (Digit Inflammation) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Measure inflammation in fingers and toes
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: H.P. Acthar Gel SQ injection
Open-label H.P. Acthar Gel 80 units subcutaneously twice weekly for 12 weeks with a 12 week extension.
Drug: Open label H.P. Acthar Gel
Open-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension.
Other Name: ACTH
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01939132
|United States, Michigan|
|Justus J. Fiechtner, MD, PC||Recruiting|
|Lansing, Michigan, United States, 48910|
|Contact: Tresa Montroy 517-272-9727 ext 24 firstname.lastname@example.org|
|Contact: Amanda Hutchins 517-272-9727 ext 24 email@example.com|
|Principal Investigator: Justus J Fiechtner, MD, MPH|