Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Drug: Placebo Gel
- Registration Number
- NCT02953821
- Lead Sponsor
- Mallinckrodt
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acthar Gel Acthar Gel Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks Placebo Gel Placebo Gel Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
- Primary Outcome Measures
Name Time Method British Isles Lupus Assessment Group 2004 (BILAG 2004) 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) 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.
Physician's Global Assessment (PGA) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 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 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 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 Week 20, Week 24
Trial Locations
- Locations (39)
Center for Rheumatology Immunology and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
IBIOMED Research Unit Aguascalientes
🇲🇽Aguascalientes, Mexico
Consultorio de ReumatologÃa
🇲🇽México, Mexico
Centro de Alta Especialidad en Reumatologia e Investigación del PotosÃ, SC
🇲🇽San Luis PotosÃ, Mexico
C.V. Mehta MD Medical Corporation
🇺🇸Hemet, California, United States
Paramount Medical Research & Consulting
🇺🇸Middleburg Heights, Ohio, United States
Biomedica Research Group
🇨🇱Santiago, Chile
San Marcus Research Clinic
🇺🇸Miami, Florida, United States
Office of George Timothy Kelly MD
🇺🇸Las Vegas, Nevada, United States
Centro Especializado en Investigación ClÃnica
🇲🇽Boca Del RÃo, Mexico
Inland Rheumatology Clinical Trials
🇺🇸Upland, California, United States
West Tennessee Physicians' Alliance
🇺🇸Jackson, Tennessee, United States
NewYork-Presbyterian Columbia University Medical Center
🇺🇸New York, New York, United States
DJL Clinical Research
🇺🇸Charlotte, North Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Consultorios Médicos Dr. Catalán Pellet
🇦🇷Buenos Aires, Argentina
Centro Medico Privado de ReumatologÃa
🇦🇷Tucumán, Argentina
Advanced Pharma CR
🇺🇸Miami, Florida, United States
Office of Ramesh C. Gupta, MD
🇺🇸Memphis, Tennessee, United States
Unidad de Investigación de las Enfermedades Reumáticas
🇲🇽Ciudad de mexico, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Centro Integral de Reumatologia
🇲🇽Mexico, Mexico
Centro Peninsular de Investigacion Clinica S.C.P.
🇲🇽Mérida, Mexico
Centro de Estudios ClÃnicos y Especialidades Médicas
🇲🇽Monterrey, Mexico
SMIQ
🇲🇽Queretaro, Mexico
Hospital de Apoyo Maria Auxiliadora
🇵🇪San Juan De Miraflores, Peru
Millennium Research
🇺🇸Ormond Beach, Florida, United States
Arthritis & Rheumatology Center of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
🇲🇽Durango, Mexico
Accelerium Clinical Research
🇲🇽Monterrey, Mexico
Phylasis Clinicas Research S de RL de CV
🇲🇽Cuautitlan Izcalli, Mexico
Köhler and Milstein Research
🇲🇽Mérida, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
🇲🇽Zapopan, Mexico
Clinica Vesalio
🇵🇪San Borja, Peru
Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
🇵🇪Lima, Peru
Hospital Nacional Cayetano Heredia
🇵🇪San Martin De Porres, Peru
Aprillus Asistencia e Investigación
🇦🇷Buenos Aires, Argentina