NCT02779153

Acthar SLE (Systemic Lupus Erythematosus)

Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus Erythematosus

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Repository Corticotropin Injection

Interventions

Type	Name	Description
DRUG	Acthar low dose (40 U)	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.
DRUG	Acthar high dose (80 U)	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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-05-22
• Completion: 2019-05-22
• First posted: 2016-05-20
• Last updated: 2019-09-13