Acthar for the Treatment of Systemic Lupus Erythematosus in Patients With a History of Persistently Active Disease
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE. This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement. The study will involve two phases: a double-blind phase, to provide placebo-controlled safety, efficacy, and pharmacodynamic data, and an optional open-label phase, to examine the prolonged effects of Acthar maintenance.
| Condition | Intervention | Phase |
|---|---|---|
|
Systemic Lupus Erythematosus (SLE) |
Drug: Acthar Drug: Placebo for Acthar |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease |
- Proportion of patients that meet the definition of a responder [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Proportion of patients meeting responder definition at Week 4:
- decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG OR
- decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG
- Proportion of patients meeting responder definition at Week 8 and Week 52 [ Time Frame: Week 8 and Week 52 ] [ Designated as safety issue: No ]
Proportion of patients meeting responder definition at Week 8 and Week 52:
- decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG OR
- decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG
- Change from baseline in SELENA-SLEDAI at Weeks 2, 4, 6, and 8 [ Time Frame: Weeks 2, 4, 6, and 8 ] [ Designated as safety issue: No ]
- Change from baseline in BILAG at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Change from baseline in tender and swollen joint counts at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Change from baseline in cutaneous lupus activity as measured by the CLASI at Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Change from baseline in SF-36 and Krupp-Fatigue Assessment in Weeks 4 and 8 [ Time Frame: Weeks 4 and 8 ] [ Designated as safety issue: No ]
- Time and rate of flare based on SFI and BILAG [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
- Proportion of patients with a relapse [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 0.5 mL Acthar
H.P. Acthar Gel 40 U (0.5 mL) daily
|
Drug: Acthar
Acthar given SC (40 U daily or 80 U every other day) for Weeks 1-4 and tapered for Weeks 5-8
Other Names:
|
|
Placebo Comparator: 0.5 mL Placebo
Placebo (0.5 mL) daily
|
Drug: Placebo for Acthar
Placebo contains the same inactive ingredients as H.P. Acthar Gel with the API. Placebo is given SC for 6 months in equal volume as the Acthar comparator.
|
|
Experimental: 1.0 mL Acthar
H.P. Acthar Gel 80 U (1.0 mL) every other day
|
Drug: Acthar
Acthar given SC (40 U daily or 80 U every other day) for Weeks 1-4 and tapered for Weeks 5-8
Other Names:
|
|
Placebo Comparator: 1.0 mL Placebo
Placebo (1.0 mL) every other day
|
Drug: Placebo for Acthar
Placebo contains the same inactive ingredients as H.P. Acthar Gel with the API. Placebo is given SC for 6 months in equal volume as the Acthar comparator.
|
Detailed Description:
The first phase of the study is an 8-week randomized, double-blind, placebo-controlled, parallel-group add-on pilot study exploring the efficacy, safety, and pharmacodynamics of Acthar in SLE patients with a history of persistently active disease with arthritic and/or cutaneous involvement despite standard of care, which includes chronic/stable prednisone use for a minimum of 4 weeks prior to screening. Patients will be randomized to one of four possible treatment groups (Acthar [low dose (40 U [0.5 mL]) or high dose (80 U [1.0 mL])] or equivalent volumes of Placebo [low or high 'dose']) in a 2:1:2:1 ratio (Acthar:Placebo:Acthar:Placebo). In Weeks 1-4, patients will administer study medication via subcutaneous (SC) injection 0.5 mL daily or 1.0 mL every other day based on randomization. In Weeks 5-8, patients will taper the study medication. Patients will continue on their stable steroid regimen during this phase of the study.
After completion of Week 8 in the double-blind phase, patients may choose to participate in the optional open-label phase where they will receive an Acthar maintenance regimen for 44 weeks. The initial Acthar regimen will be assigned based on the study medication regimen the patient received at the completion of the double-blind phase (Visit 6, Week 8). Acthar regimen may be adjusted based on the Investigator's judgment with the goal of achieving a stable Acthar regimen no later than Week 28. Once the stable Acthar regimen is achieved, the Investigator should consider tapering the steroid regimen to a low daily dose or completely discontinue.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female ≥ 18 years of age at screening who are able to provide informed consent
- Diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled ≥ 4 criteria)
- Active SLE with arthritic and/or cutaneous involvement as demonstrated by a SELENA-SLEDAI score ≥ 2 (clinical manifestation must include rash and/or arthritis)
- Moderate to severe rash and/or arthritis as demonstrated by BILAG score A or B in the mucocutaneous and/or musculoskeletal body systems
- Documented history of autoantibodies to at least one of the following: anti-dsDNA, anti-Smith, or anti-cardiolipin
- Documented history of positive antinuclear antibody (ANA)
- Currently on a stable dose of prednisone (7.5 to 30 mg/day of prednisone or equivalent within the 4 weeks prior to screening). The prednisone regimen must remain stable through the double-blind phase and until the stable Acthar regimen is attained in the open-label phase.
Exclusion Criteria:
- Patients with a recent history (≤ 2 months prior to screening) of starting prednisone (or equivalent) use
- Patients with active nephritis defined as serum creatinine > 2.5 mg/dL or protein creatinine ratio (PCR) > 1.5 g/g, or patients that required hemodialysis within 3 months prior to screening
- Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis), requiring therapeutic intervention within 3 months prior to screening
- Type 1 or type 2 diabetes mellitus (history of gestational diabetes mellitus is not an exclusion), or patients currently taking hypoglycemic medication
History of using certain medications prior to screening:
- oral prednisone (or equivalent) > 30 mg/day, any steroid injection, cyclosporine, or non-biologic investigational drug within 3 months prior to screening
- IVIg or plasmapheresis within 4 months prior to screening
- cyclophosphamide within 6 months prior to screening; and/or
- B-cell targeted therapy, abatacept, or any biologic investigational agent within 12 months prior to screening
Contraindication per Acthar Prescribing Information: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction
- For the purposes of this study, osteoporosis is defined as evidence of vertebral or long bone fracture or vertebral T-score > 2.0
- For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening
- For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV
Contacts and Locations| Contact: Shanique Smythe, MS | 443-973-2012 | shanique.smythe@questcor.com |
| United States, California | |
| University of California San Diego | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| Principal Investigator: Kenneth Kalunian, MD | |
| Valerius Medical Group and Research Center | Recruiting |
| Long Beach, California, United States, 90806 | |
| Principal Investigator: Nathaniel Neal, MD | |
| United States, Florida | |
| Clinical Research of West Florida, Inc | Recruiting |
| Clearwater, Florida, United States, 33765 | |
| Principal Investigator: Robert Levin, MD | |
| Burnette & Silverfield MDs, PLC | Recruiting |
| Tampa, Florida, United States, 33614 | |
| Principal Investigator: Michael Burnette, MD | |
| United States, Indiana | |
| Memorial Health System Inc | Recruiting |
| Granger, Indiana, United States, 46530 | |
| Principal Investigator: Nicholas Straniero, MD | |
| United States, Louisiana | |
| Ochsner Clinic Foundation | Not yet recruiting |
| Baton Rouge, Louisiana, United States, 70809 | |
| Principal Investigator: Stephen Lindsey, MD | |
| United States, Maryland | |
| Johns Hopkins University | Not yet recruiting |
| Baltimore, Maryland, United States, 21209 | |
| Principal Investigator: Michelle Petri, MD | |
| United States, Michigan | |
| Clinical Trials Office - Henry Ford Health System | Not yet recruiting |
| Detroit, Michigan, United States, 48202 | |
| Principal Investigator: Kathleen McKinnon, MD | |
| Fiechtner Research, Inc. | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Principal Investigator: Justus Fiechtner, MD | |
| United States, New York | |
| North Shore-Long Island Health System | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Principal Investigator: Richard Furie, MD | |
| United States, North Carolina | |
| Arthritis and Rheumatology of the Carolinas, PLLC | Recruiting |
| Charlotte, North Carolina, United States, 28210 | |
| Principal Investigator: Emily Jane Herron Box, MD | |
| United States, Pennsylvania | |
| Penn State University | Not yet recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: Nancy Olsen, MD | |
| United States, Texas | |
| Rheumatic Disease Clinical Research | Recruiting |
| Houston, Texas, United States, 77004 | |
| Principal Investigator: Samuel Pegram, MD | |
| Accurate Clinical Research | Recruiting |
| Houston, Texas, United States, 77034 | |
| Principal Investigator: Philip Waller, MD | |
| Principal Investigator: | Richard Furie, MD | North Shore Long Island Health System |
More Information
No publications provided
| Responsible Party: | Questcor Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01753401 History of Changes |
| Other Study ID Numbers: | QSC01-SLE-01 |
| Study First Received: | December 17, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Questcor Pharmaceuticals, Inc.:
|
SLE Lupus |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adrenocorticotropic Hormone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013