Phase 4
N=172
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Lupus Erythematosus, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT02953821 ↗Enrolled (actual)
172
Serious AEs
7.0%
Results posted
Aug 2020
Primary outcome: Primary: Physician's Global Assessment (PGA) — 58.8; 60.6; 33.2; 30.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Acthar Gel (Drug); Placebo Gel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Jul 2019
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 | — |
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
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). 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.