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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
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 3, 2016
Results First Submitted Date  ICMJE July 8, 2020
Results First Posted Date  ICMJE August 20, 2020
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE December 16, 2016
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Physician's Global Assessment (PGA) [ Time Frame: Baseline, Week 16, Week 24 ]
    PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
  • British Isles Lupus Assessment Group 2004 (BILAG 2004) [ Time Frame: Baseline, Week 16, Week 24 ]
    BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
  • Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) [ Time Frame: Week 16, Week 24 ]
    The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Proportion of responders assessed by the SLE Responder Index [ Time Frame: 16 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 [ Time Frame: Week 16 ]
    Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe.
  • Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score [ Time Frame: at Baseline and Weeks 4, 8, and 16 ]
    The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement.
  • Mean Number of Swollen or Tender Joints on the 28-Joint Count [ Time Frame: at Baseline and at Weeks 4, 8, 12 and 16 ]
    The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
  • Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 [ Time Frame: Week 20, Week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Change from baseline in SLE disease activity measure [ Time Frame: 16 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE 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
Brief Summary

This trial is to study Acthar Gel in participants 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, which looks like Acthar Gel, 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
Detailed Description This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Drug: Acthar Gel
    1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
    Other Name: Repository corticotropin
  • Drug: Placebo Gel
    1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
    Other Name: Matching placebo
Study Arms  ICMJE
  • Experimental: Acthar Gel
    Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
    Intervention: Drug: Acthar Gel
  • Placebo Comparator: Placebo Gel
    Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
    Intervention: Drug: Placebo Gel
Publications * Askanase AD, Zhao E, Zhu J, Bilyk R, Furie RA. Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Rheumatol Ther. 2020 Dec;7(4):893-908. doi: 10.1007/s40744-020-00236-1. Epub 2020 Sep 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
172
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
162
Actual Study Completion Date  ICMJE October 25, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 moderate to severe rash and/or arthritis as demonstrated by BILAG-2004 score A or B in the mucocutaneous and/or musculoskeletal body systems at both Screening and Randomization Visits
  • Have a documented history or screening result of

    1. positive antinuclear antibody (ANA), OR
    2. elevated anti-dsDNA or extractable nuclear antigen (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 adrenocorticotropic hormone (ACTH) preparations or porcine products
  • Has active lupus nephritis
  • Has active central nervous system (CNS) manifestations of SLE
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Mexico,   Peru,   United States
Removed Location Countries Colombia
 
Administrative Information
NCT Number  ICMJE NCT02953821
Other Study ID Numbers  ICMJE MNK14304067
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mallinckrodt
Study Sponsor  ICMJE Mallinckrodt
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Leader Mallinckrodt
PRS Account Mallinckrodt
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP