Back to resultsActhar Gel for Active Systemic Lupus Erythematosus (SLE)
Primary Purpose
Lupus Erythematosus, Systemic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Acthar Gel
Placebo Gel
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic
Eligibility 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 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
- positive antinuclear antibody (ANA), OR
- elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
Have been on prednisone (or prednisone equivalent) before the screening visit:
- at least 8 weeks, and
- 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
Sites / Locations
- C.V. Mehta MD Medical Corporation
- Inland Rheumatology Clinical Trials
- Center for Rheumatology Immunology and Arthritis
- San Marcus Research Clinic
- Advanced Pharma CR
- Millennium Research
- Office of George Timothy Kelly MD
- NewYork-Presbyterian Columbia University Medical Center
- DJL Clinical Research
- Paramount Medical Research & Consulting
- Arthritis & Rheumatology Center of Oklahoma
- Altoona Center for Clinical Research
- West Tennessee Physicians' Alliance
- Office of Ramesh C. Gupta, MD
- Accurate Clinical Research
- Sun Research Institute
- Aprillus Asistencia e Investigación
- Consultorios Médicos Dr. Catalán Pellet
- Centro Medico Privado de Reumatología
- Biomedica Research Group
- Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
- IBIOMED Research Unit Aguascalientes
- Centro Especializado en Investigación Clínica
- Unidad de Investigación de las Enfermedades Reumáticas
- Phylasis Clinicas Research S de RL de CV
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
- Centro Integral de Reumatologia
- Accelerium Clinical Research
- Centro de Estudios Clínicos y Especialidades Médicas
- Centro Peninsular de Investigacion Clinica S.C.P.
- Köhler and Milstein Research
- Consultorio de Reumatología
- SMIQ
- Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
- Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
- Clinica Vesalio
- Hospital de Apoyo Maria Auxiliadora
- Hospital Nacional Cayetano Heredia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acthar Gel
Placebo Gel
Arm Description
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Outcomes
Primary Outcome Measures
Physician's Global Assessment (PGA)
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)
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)
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.
Secondary Outcome Measures
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at 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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02953821
Brief Title
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 16, 2016 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
172 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acthar Gel
Arm Type
Experimental
Arm Description
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Arm Title
Placebo Gel
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Intervention Type
Drug
Intervention Name(s)
Acthar Gel
Other Intervention Name(s)
Repository corticotropin
Intervention Description
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Intervention Type
Drug
Intervention Name(s)
Placebo Gel
Other Intervention Name(s)
Matching placebo
Intervention Description
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Primary Outcome Measure Information:
Title
Physician's Global Assessment (PGA)
Description
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Time Frame
Baseline, Week 16, Week 24
Title
British Isles Lupus Assessment Group 2004 (BILAG 2004)
Description
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.
Time Frame
Baseline, Week 16, Week 24
Title
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
Description
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.
Time Frame
Week 16, Week 24
Secondary Outcome Measure Information:
Title
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
Description
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.
Time Frame
Week 16
Title
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Description
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.
Time Frame
at Baseline and Weeks 4, 8, and 16
Title
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Description
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.
Time Frame
at Baseline and at Weeks 4, 8, 12 and 16
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
positive antinuclear antibody (ANA), OR
elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
Have been on prednisone (or prednisone equivalent) before the screening visit:
at least 8 weeks, and
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
C.V. Mehta MD Medical Corporation
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Center for Rheumatology Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Advanced Pharma CR
City
Miami
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
Facility Name
Millennium Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Office of George Timothy Kelly MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
NewYork-Presbyterian Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Paramount Medical Research & Consulting
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Arthritis & Rheumatology Center of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
West Tennessee Physicians' Alliance
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Office of Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Aprillus Asistencia e Investigación
City
Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
Consultorios Médicos Dr. Catalán Pellet
City
Buenos Aires
ZIP/Postal Code
C1111AAL
Country
Argentina
Facility Name
Centro Medico Privado de Reumatología
City
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
IBIOMED Research Unit Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20010
Country
Mexico
Facility Name
Centro Especializado en Investigación Clínica
City
Boca Del Río
ZIP/Postal Code
94290
Country
Mexico
Facility Name
Unidad de Investigación de las Enfermedades Reumáticas
City
Ciudad de mexico
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Phylasis Clinicas Research S de RL de CV
City
Cuautitlan Izcalli
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Centro Integral de Reumatologia
City
Mexico
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Accelerium Clinical Research
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Centro de Estudios Clínicos y Especialidades Médicas
City
Monterrey
ZIP/Postal Code
64620
Country
Mexico
Facility Name
Centro Peninsular de Investigacion Clinica S.C.P.
City
Mérida
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Köhler and Milstein Research
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Consultorio de Reumatología
City
México
ZIP/Postal Code
07760
Country
Mexico
Facility Name
SMIQ
City
Queretaro
ZIP/Postal Code
76090
Country
Mexico
Facility Name
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
City
Lima
Country
Peru
Facility Name
Clinica Vesalio
City
San Borja
ZIP/Postal Code
15036
Country
Peru
Facility Name
Hospital de Apoyo Maria Auxiliadora
City
San Juan De Miraflores
ZIP/Postal Code
15801
Country
Peru
Facility Name
Hospital Nacional Cayetano Heredia
City
San Martin De Porres
ZIP/Postal Code
15102
Country
Peru
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34478124
Citation
Askanase AD, Wright D, Zhao E, Zhu J, Bilyk R, Furie RA. Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Dec;8(4):1871-1886. doi: 10.1007/s40744-021-00351-7. Epub 2021 Sep 3.
Results Reference
derived
PubMed Identifier
33687687
Citation
Askanase AD, Wan GJ, Panaccio MP, Zhao E, Zhu J, Bilyk R, Furie RA. Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar(R) Gel) for Persistently Active Systemic Lupus Erythematosus. Rheumatol Ther. 2021 Mar;8(1):573-584. doi: 10.1007/s40744-021-00294-z. Epub 2021 Mar 9.
Results Reference
derived
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
PubMed Identifier
32996096
Citation
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. Erratum In: Rheumatol Ther. 2021 Dec;8(4):1915.
Results Reference
derived
Learn more about this trial
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
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