Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (ACTH)
Lupus Erythematosus Systemic Exacerbation
Drug: H.P. Acthar Gel
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 Systemic Lupus Erythematosus (SLE)|
- SLEDAI-2K score [ Time Frame: 14 days ] [ Designated as safety issue: No ]The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
- BILAG-2004 [ Time Frame: 14 days ] [ Designated as safety issue: No ]To evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g. ESR and/or CRP.
- Fatigue (FACIT-FATIGUE) [ Time Frame: 14 days ] [ Designated as safety issue: No ]This study will investigate the effects of Acthar on other endpoints such as Fatigue (FACIT-FATIGUE), Lupus Quality of Life (LupusQoL), and painful, swollen and tender joint counts
|Study Start Date:||October 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: H.P. Acthar Gel SQ injection
Patients will administer single dose (80 units) of Acthar subcutaneously every day for 10 days (with a possible 5 day dosing rescue).
Drug: H.P. Acthar Gel
Open-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing
Other Name: ACTH
This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P. Acthar Gel.
The primary objective is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g. ESR and/or CRP.
The Exploratory objective will determine the feasibility of a long-term double-blind study using H.P. Acthar Gel versus other usual treatments for lupus.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769937
|United States, Michigan|
|Justus J. Fiechtner|
|Lansing, Michigan, United States, 48910|
|Principal Investigator:||Justus J Fiechtner, MD, MPH||Justus J. Fiechtner, MD, PC|