Phase 4
Completed N=172
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Lupus Erythematosus, Systemic
Source: ClinicalTrials.gov NCT02953821 ↗
Enrolled (actual)
172
Serious AEs
7.0%
Results posted
Aug 2020
Primary outcomePrimary: Physician's Global Assessment (PGA) — 58.8; 60.6; 33.2; 30.2 score on a scale
◆ Published Evidence
Established
40citations · ~8 / year
Interventions for cutaneous disease in systemic lupus erythematosus.
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
Linked Publications (4)
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Interventions for cutaneous disease in systemic lupus erythematosus.
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Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
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Patient-Reported Outcomes from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar<sup>®</sup> Gel) for Persistently Active Systemic Lupus Erythematosus.
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Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician's Global Assessment (PGA) |
58.8; 60.6; 33.2; 30.2; 26.9; 25.5 | — |
| PRIMARY British Isles Lupus Assessment Group 2004 (BILAG 2004) |
18.2; 18.0; 9.7; 7.7; 8.0; 6.9 | — |
| PRIMARY Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) |
40; 41; 46; 44 | — |
| SECONDARY Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 |
3; 0 | — |
| SECONDARY Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score |
7.1; 7.9; 5.8; 5.6; 5.0; 5.0 | — |
| SECONDARY Mean Number of Swollen or Tender Joints on the 28-Joint Count |
7.2; 8.2; 4.9; 4.2; 3.8; 2.9 | — |
| SECONDARY Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24 |
5; 3; 6; 4 | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02953821) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.