Lupus Erythematosus, SystemicPhase 4NCT02953821
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
A Phase 4 study testing Acthar Gel in people with Lupus Erythematosus, Systemic, run by Mallinckrodt at 39 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Acthar Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 39 sitesin 5 countries
- Study dates
- 16 Dec 2016to 25 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
United States16 sites
DJL Clinical Research
Charlotte, North Carolina, 28210
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, 33309
C.V. Mehta MD Medical Corporation
Hemet, California, 92543
Accurate Clinical Research
Houston, Texas, 77034
West Tennessee Physicians' Alliance
Jackson, Tennessee, 38305
Office of George Timothy Kelly MD
Las Vegas, Nevada, 89128
Office of Ramesh C. Gupta, MD
Memphis, Tennessee, 38119
San Marcus Research Clinic
Miami, Florida, 33015
Advanced Pharma CR
Miami, Florida, 33147
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, 44130
NewYork-Presbyterian Columbia University Medical Center
New York, New York, 10032
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, 73103
Millennium Research
Ormond Beach, Florida, 32174
Sun Research Institute
San Antonio, Texas, 78215
Inland Rheumatology Clinical Trials
Upland, California, 91786
Mexico15 sites
IBIOMED Research Unit Aguascalientes
Aguascalientes, 20010
Centro Especializado en Investigación Clínica
Boca del Río, 94290
Phylasis Clinicas Research S de RL de CV
Cuautitlán Izcalli, 54769
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango, 34000
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
Centro Peninsular de Investigacion Clinica S.C.P.
Mérida, 97000
Köhler and Milstein Research
Mérida, 97070
Consultorio de Reumatología
México, 07760
Centro Integral de Reumatologia
México, 44160
Unidad de Investigación de las Enfermedades Reumáticas
Mexico City, 06090
Accelerium Clinical Research
Monterrey, 64000
Centro de Estudios Clínicos y Especialidades Médicas
Monterrey, 64620
SMIQ
Querétaro, 76090
Centro de Alta Especialidad en Reumatologia e Investigación del Potosí, SC
San Luis Potosí City, 78213
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
Zapopan, 45030
Peru4 sites
Investigaciones Clinicas S.A.C. del Instituto de Ginecologia y Reproduccion
Lima
Clinica Vesalio
San Borja, 15036
Hospital de Apoyo Maria Auxiliadora
San Juán de Miraflores, 15801
Hospital Nacional Cayetano Heredia
San Martín de Porres, 15102
Argentina3 sites
Aprillus Asistencia e Investigación
Buenos Aires, C1046AAQ
Consultorios Médicos Dr. Catalán Pellet
Buenos Aires, C1111AAL
Centro Medico Privado de Reumatología
San Miguel de Tucumán, T4000AXL
About this study
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
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
Read the detailed description
This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Acthar Gel, Placebo Gel
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar GelDrug
Also called Repository corticotropin
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Placebo GelDrug
Also called Matching placebo
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
| Study group | Role | What they receive |
|---|---|---|
| Acthar Gel | Experimental | Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks Receives: Drug: Acthar Gel |
| Placebo Gel | Placebo comparator | Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 16, Week 24
Secondary outcomes (4)
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.
Measured: Week 16
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.
Measured: 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.
Measured: 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
Measured: Week 20, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start16 Dec 2016
- Primary completion31 Jul 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953821
- Sponsor's protocol ID
- MNK14304067
- Status last verified
- Aug 2020
- First submitted
- 1 Nov 2016
- Last updated
- 20 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34478124Askanase 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.
PubMed 33687687Hannon 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.
PubMed 33687069Askanase 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.
PubMed 32996096
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02953821
- Acronym / sponsor ID
- MNK14304067
- Conditions
- Lupus Erythematosus, Systemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Posted 20 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acthar Gel | Experimental | Drug: Acthar GelParticipants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks |
| Placebo Gel | Placebo comparator | Drug: Placebo GelParticipants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar GelAlso: Repository corticotropin1 mL (80 Units) given by a shot under the skin (via subcutaneous injection) | Drug | Acthar Gel |
| Placebo GelAlso: Matching placebo1 mL (0 Units) given by a shot under the skin (via subcutaneous injection) | Drug | Placebo Gel |
Primary outcome
Physician's Global Assessment (PGA)
Time frame: 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.
British Isles Lupus Assessment Group 2004 (BILAG 2004)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
Time frame: Week 16
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Time frame: at Baseline and Weeks 4, 8, and 16
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Time frame: 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
Time frame: Week 20, Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34478124Askanase 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.
- Derived from this study: PubMed 33687687Askanase 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.
- Derived from this study: PubMed 33687069Hannon 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.
- Derived from this study: PubMed 32996096Askanase 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Mallinckrodt
39 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar Gel in people with Lupus Erythematosus, Systemic, run by Mallinckrodt at 39 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Mexico, Peru, Argentina, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's Global Assessment (PGA) (time frame: Baseline, Week 16, Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953821, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.