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Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953821
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:

This study is to find out if Acthar Gel might help patients with active systemic lupus erythematosus (SLE).

The doctor will assign eligible patients to one of two groups (like flipping a coin).

Participants will receive the treatment assigned to their group for 24 weeks:

  • Acthar Gel
  • Placebo Gel Placebo Gel looks like Acthar, but has no medicine in it.

The doctor or his staff will take measurements and ask questions to:

  • see how well the gel is working
  • see how safe it is for patients with SLE

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: Acthar Gel Drug: Placebo Gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids
Actual Study Start Date : October 13, 2016
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : October 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Drug: Acthar Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Other Name: Repository corticotropin

Placebo Comparator: Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Drug: Placebo Gel
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Other Name: Matching placebo




Primary Outcome Measures :
  1. Number of participants classified as responders [ Time Frame: 16 Weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible to participate in this trial, a patient must:

  • Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria
  • Have active SLE
  • Have a documented history or screening result of

    1. positive antinuclear antibody (ANA), OR
    2. elevated anti-dsDNA or ENA antibodies
  • Have been on prednisone (or prednisone equivalent) before the screening visit:

    1. at least 8 weeks, and
    2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks

Exclusion criteria:

A patient is not eligible to participate if he/she:

  • Has a history of sensitivity to ACTH preparations or non-bovine products.
  • Has active lupus nephritis
  • Has active central nervous system (CNS) manifestations of SLE

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953821


Locations
Show Show 39 study locations
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Global Clinical Leader Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT02953821    
Other Study ID Numbers: MNK14304067
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs