Clinical trial NCT02953821: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Erythematosus, Systemic
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  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

Primary outcomes:
measure: Physician's Global Assessment (PGA)
timeFrame: Baseline, Week 16, Week 24
measure: British Isles Lupus Assessment Group 2004 (BILAG 2004)
timeFrame: Baseline, Week 16, Week 24
measure: Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
timeFrame: Week 16, Week 24
Secondary outcomes:
measure: Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
timeFrame: Week 16
measure: Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
timeFrame: at Baseline and Weeks 4, 8, and 16
measure: Mean Number of Swollen or Tender Joints on the 28-Joint Count
timeFrame: at Baseline and at Weeks 4, 8, 12 and 16
measure: Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
timeFrame: Week 20, Week 24
Other outcomes:
Locations:
city: Hemet
country: United States
facility: C.V. Mehta MD Medical Corporation
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials
state: California
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology Immunology and Arthritis
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Las Vegas
country: United States
facility: Office of George Timothy Kelly MD
state: Nevada
city: New York
country: United States
facility: NewYork-Presbyterian Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center of Oklahoma
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Jackson
country: United States
facility: West Tennessee Physicians' Alliance
state: Tennessee
city: Memphis
country: United States
facility: Office of Ramesh C. Gupta, MD
state: Tennessee
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Buenos Aires
country: Argentina
facility: Aprillus Asistencia e Investigación
city: Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Catalán Pellet
city: Tucumán
country: Argentina
facility: Centro Medico Privado de Reumatología
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Guadalajara
country: Mexico
facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Aguascalientes
country: Mexico
facility: IBIOMED Research Unit Aguascalientes
city: Boca Del Río
country: Mexico
facility: Centro Especializado en Investigación Clínica
city: Ciudad de mexico
country: Mexico
facility: Unidad de Investigación de las Enfermedades Reumáticas
city: Cuautitlan Izcalli
country: Mexico
facility: Phylasis Clinicas Research S de RL de CV
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Mexico
country: Mexico
facility: Centro Integral de Reumatologia
city: Monterrey
country: Mexico
facility: Accelerium Clinical Research
city: Monterrey
country: Mexico
facility: Centro de Estudios Clínicos y Especialidades Médicas
city: Mérida
country: Mexico
facility: Centro Peninsular de Investigacion Clinica S.C.P.
city: Mérida
country: Mexico
facility: Köhler and Milstein Research
city: México
country: Mexico
facility: Consultorio de Reumatología
city: Queretaro
country: Mexico
facility: SMIQ
city: San Luis Potosí
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
city: Lima
country: Peru
facility: Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
city: San Borja
country: Peru
facility: Clinica Vesalio
city: San Juan De Miraflores
country: Peru
facility: Hospital de Apoyo Maria Auxiliadora
city: San Martin De Porres
country: Peru
facility: Hospital Nacional Cayetano Heredia
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.