Withdrawn
PHASE4
INTERVENTIONAL
NCT02779153
Acthar SLE (Systemic Lupus Erythematosus)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
This is a randomized study exploring the efficacy, safety and steroid sparing ability of two doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic manifestations requiring steroid use for a minimum of 2 weeks prior to screening.
Detailed Description
Acthar is currently labeled for use during an exacerbation or for maintenance therapy in selected SLE cases, however data from prospective trials on hematologic manifestations of SLE are not available. Due to the potential effect of lowering or eliminating autoantibodies, the absence of bone marrow suppression, and a steroid sparing effect, Acthar may represent a novel therapeutic option in recalcitrant cases of hematologic SLE.
Interventions
Name:
Acthar low dose (40 U)
Type:
DRUG
Description:
The 40U group will administer 0.5 mL of study medication once a day. Patients will taper study medication during Week 2 through the remainder of the study and will administer 0.5 mL of study medication twice a week. The stable Acthar regimen should be maintained for the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Name:
Acthar high dose (80 U)
Type:
DRUG
Description:
The 80U group will administer 1.0 mL of study medication every day. If a patient meets dose reduction criteria, their assigned volume will be adjusted from 1.0 mL to 0.5 mL. Patients will taper study medication during Week 2 through the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Primary Outcomes
Measure:
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score
TimeFrame:
Baseline to Week 24
Description:
Disease activity is based on 24 questions, weighted across nine organ systems, combined into a total score that can range from 0 to 105, but are generally \< 20, even with very active disease.
Measure:
British Isles Lupus Assessment Group (BILAG) disease activity index Score
TimeFrame:
Baseline to Week 24
Description:
Items are rated as 0 (not present), 1 (improving), 2 (same), 3 (worse), or 4 (new) in the last 4 weeks compared with the previous 4 weeks. The numerical scores are used to categorize each organ system by an alphabetical score: 'A' reflecting severe disease requiring increases in prednisone to \> 20 mg daily and/or addition of immunosuppressive agents, 'B' indicated less active disease, requiring low-dose prednisone and/or symptomatic treatment with NSAIDs and/or antimalarials, 'C' reflecting mild disease requiring only symptomatic therapy, 'D' reflecting previous organ system involvement without current disease activity, and 'E' reflecting no prior or no current disease involvement in that organ system.
Measure:
Physician's Global Assessment Score
TimeFrame:
Baseline to Week 24
Description:
The Physician's Global Assessment is a 10 cm visual analogue scale (VAS) anchored at 0 (none) and 3 (severe) with intermediate lines at 1 (mild) and 2 (moderate). It is designed for the physician to indicate the patient's overall disease activity at a particular visit
Measure:
SELENA Flare Index Score
TimeFrame:
Baseline to Week 24
Description:
The SELENA Flare Index categorizes SLE flare as 'mild or moderate' or 'severe' based on six variables
* Change in SLEDAI score from the most recent assessment to current.
* Change in signs or symptoms of disease activity.
* Change in prednisone dosage.
* Use of new medication for disease activity or hospitalization.
* Change in PGA score.
* Hospitalization for SLE activity (severe flare only).
Measure:
SLICC/ACR Damage Index
TimeFrame:
Baseline to Week 24
Description:
The SLICC/ACR Damage Index measures irreversible organ damage from either the disease process or treatment, which has been present for ≥ 6 months, in 12 organ systems. It is an important predictor of long-term mortality and is an independent outcome measure separate from the SLEDAI.
Trial Information
NCT ID
NCT02779153
Status
Withdrawn
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
NYU Langone Health
Last Updated
December 15, 2025