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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:
The doctor or his staff will take measurements and ask questions to:
This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acthar Gel | Experimental | Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks |
|
| Placebo Gel | Placebo Comparator | Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar Gel | Drug | 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16, Week 24 |
| 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. | Baseline, Week 16, Week 24 |
| 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. | Week 16, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
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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
Have been on prednisone (or prednisone equivalent) before the screening visit:
Exclusion criteria:
A patient is not eligible to participate if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.V. Mehta MD Medical Corporation | Hemet | California | 92543 | United States | ||
| Inland Rheumatology Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34478124 | Derived | 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. | |
| 33687687 |
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Of 293 who signed informed consent, 172 were randomized into treatment groups
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Gel | Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection) |
| FG001 | Acthar Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2017 |
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| Placebo Gel | Drug | 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection) |
|
|
| 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. |
| at Baseline and Weeks 4, 8, and 16 |
| 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. | at Baseline and at Weeks 4, 8, 12 and 16 |
| Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 | Week 20, Week 24 |
| Upland |
| California |
| 91786 |
| United States |
| Center for Rheumatology Immunology and Arthritis | Fort Lauderdale | Florida | 33309 | United States |
| San Marcus Research Clinic | Miami | Florida | 33015 | United States |
| Advanced Pharma CR | Miami | Florida | 33147 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| Office of George Timothy Kelly MD | Las Vegas | Nevada | 89128 | United States |
| NewYork-Presbyterian Columbia University Medical Center | New York | New York | 10032 | United States |
| DJL Clinical Research | Charlotte | North Carolina | 28210 | United States |
| Paramount Medical Research & Consulting | Middleburg Heights | Ohio | 44130 | United States |
| Arthritis & Rheumatology Center of Oklahoma | Oklahoma City | Oklahoma | 73103 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| West Tennessee Physicians' Alliance | Jackson | Tennessee | 38305 | United States |
| Office of Ramesh C. Gupta, MD | Memphis | Tennessee | 38119 | United States |
| Accurate Clinical Research | Houston | Texas | 77034 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Aprillus Asistencia e Investigación | Buenos Aires | C1046AAQ | Argentina |
| Consultorios Médicos Dr. Catalán Pellet | Buenos Aires | C1111AAL | Argentina |
| Centro Medico Privado de Reumatología | San Miguel de Tucumán | T4000AXL | Argentina |
| Biomedica Research Group | Santiago | 7500710 | Chile |
| Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| IBIOMED Research Unit Aguascalientes | Aguascalientes | 20010 | Mexico |
| Centro Especializado en Investigación Clínica | Boca del Río | 94290 | Mexico |
| Phylasis Clinicas Research S de RL de CV | Cuautitlán Izcalli | 54769 | Mexico |
| Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango | 34000 | Mexico |
| Unidad de Investigación de las Enfermedades Reumáticas | Mexico City | 06090 | Mexico |
| Centro Peninsular de Investigacion Clinica S.C.P. | Mérida | 97000 | Mexico |
| Köhler and Milstein Research | Mérida | 97070 | Mexico |
| Consultorio de Reumatología | México | 07760 | Mexico |
| Centro Integral de Reumatologia | México | 44160 | Mexico |
| Accelerium Clinical Research | Monterrey | 64000 | Mexico |
| Centro de Estudios Clínicos y Especialidades Médicas | Monterrey | 64620 | Mexico |
| SMIQ | Querétaro | 76090 | Mexico |
| Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC | San Luis Potosí City | 78213 | Mexico |
| Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Zapopan | 45030 | Mexico |
| Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion | Lima | Peru |
| Clinica Vesalio | San Borja | 15036 | Peru |
| Hospital de Apoyo Maria Auxiliadora | San Juán de Miraflores | 15801 | Peru |
| Hospital Nacional Cayetano Heredia | San Martín de Porres | 15102 | Peru |
| 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. |
| 33687069 | Derived | 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. |
| 32996096 | Derived | 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. |
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
| Safety Population |
|
| Modified Intent to Treat (mITT) Populati |
|
| Per Protocol (PP) Population |
|
| Completed Week 16 Visit |
|
| Completed Study Treatment (Week 24) |
|
| COMPLETED | including follow-up |
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| NOT COMPLETED |
|
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Safety Population (except for study-specific measures)
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Gel | Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection) |
| BG001 | Acthar Gel | Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | mITT population with score at the given week | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16, Week 24 |
|
|
| ||||||||||||||||||||||||||||
| Primary | 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. | mITT population with a score at the given week | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 16, Week 24 |
| ||||||||||||||||||||||||||||||
| Primary | 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. | modified Intent to Treat (mITT) | Posted | Count of Participants | Participants | Week 16, Week 24 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | mITT population | Posted | Count of Participants | Participants | Week 16 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | mITT population with scores at the given week | Posted | Mean | Standard Deviation | score on a scale | at Baseline and Weeks 4, 8, and 16 |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | mITT population with tender and swollen joints at the given week | Posted | Mean | Standard Deviation | Joints | at Baseline and at Weeks 4, 8, 12 and 16 | Joints | Joints |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 | mITT Population | Posted | Count of Participants | Participants | Week 20, Week 24 |
|
|
24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Gel | Participants receive Placebo Gel | 1 | 86 | 8 | 86 | 23 | 86 |
| EG001 | Acthar Gel | Participants receive Acthar Gel | 0 | 86 | 4 | 86 | 31 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | 5 | clinicaltrials@mnk.com |
| Jul 7, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| Week 16 |
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| Week 24 |
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| Participants |
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| Joints |
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