Protocol for H.P. Acthar Gel in Moderately to Severely Active Psoriatic Arthritis
|ClinicalTrials.gov Identifier: NCT01939132|
Recruitment Status : Unknown
Verified September 2013 by Fiechtner, Justus J., M.D., P.C..
Recruitment status was: Recruiting
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Psoriatic Arthritis||Drug: Open label H.P. Acthar Gel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||November 2014|
U.S. FDA Resources
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
- ACR20 (American College of Rheumatology 20) [ Time Frame: Week 12 ]
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 ]Adverse events and vital signs will be measured and monitored for 24 weeks.
- Clinical Disease Activity Index (CDAI) [ Time Frame: 12 weeks ]
- Disease Activity Index 28 (DAS28) [ Time Frame: 12 weeks ]
- Dactylitis (Digit Inflammation) [ Time Frame: 12 weeks ]Measure inflammation in fingers and toes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|