Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Systemic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953821
• Other study ID #: MNK14304067
• Status: Completed
• Phase: Phase 4
• Start date: December 16, 2016
• Est. completion date: October 25, 2019

Study information

• Verified date: August 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 25, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• Acthar Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
• Placebo Gel
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)

Locations

Country	Name	City	State
Argentina	Aprillus Asistencia e Investigación	Buenos Aires
Argentina	Consultorios Médicos Dr. Catalán Pellet	Buenos Aires
Argentina	Centro Medico Privado de Reumatología	Tucumán
Chile	Biomedica Research Group	Santiago
Mexico	IBIOMED Research Unit Aguascalientes	Aguascalientes
Mexico	Centro Especializado en Investigación Clínica	Boca Del Río
Mexico	Unidad de Investigación de las Enfermedades Reumáticas	Ciudad de mexico
Mexico	Phylasis Clinicas Research S de RL de CV	Cuautitlan Izcalli
Mexico	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango
Mexico	Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Centro Peninsular de Investigacion Clinica S.C.P.	Mérida
Mexico	Köhler and Milstein Research	Mérida
Mexico	Centro Integral de Reumatologia	Mexico
Mexico	Consultorio de Reumatología	México
Mexico	Accelerium Clinical Research	Monterrey
Mexico	Centro de Estudios Clínicos y Especialidades Médicas	Monterrey
Mexico	SMIQ	Queretaro
Mexico	Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC	San Luis Potosí
Mexico	Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Zapopan
Peru	Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion	Lima
Peru	Clinica Vesalio	San Borja
Peru	Hospital de Apoyo Maria Auxiliadora	San Juan De Miraflores
Peru	Hospital Nacional Cayetano Heredia	San Martin De Porres
United States	DJL Clinical Research	Charlotte	North Carolina
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Center for Rheumatology Immunology and Arthritis	Fort Lauderdale	Florida
United States	C.V. Mehta MD Medical Corporation	Hemet	California
United States	Accurate Clinical Research	Houston	Texas
United States	West Tennessee Physicians' Alliance	Jackson	Tennessee
United States	Office of George Timothy Kelly MD	Las Vegas	Nevada
United States	Office of Ramesh C. Gupta, MD	Memphis	Tennessee
United States	Advanced Pharma CR	Miami	Florida
United States	San Marcus Research Clinic	Miami	Florida
United States	Paramount Medical Research & Consulting	Middleburg Heights	Ohio
United States	NewYork-Presbyterian Columbia University Medical Center	New York	New York
United States	Arthritis & Rheumatology Center of Oklahoma	Oklahoma City	Oklahoma
United States	Millennium Research	Ormond Beach	Florida
United States	Sun Research Institute	San Antonio	Texas
United States	Inland Rheumatology Clinical Trials	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	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.	at Baseline and at Weeks 4, 8, 12 and 16
Secondary	Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24		Week 20, Week 24