Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
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| ClinicalTrials.gov Identifier: NCT02953821 |
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Recruitment Status :
Completed
First Posted : November 3, 2016
Results First Posted : August 20, 2020
Last Update Posted : August 20, 2020
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lupus Erythematosus, Systemic | Drug: Acthar Gel Drug: Placebo Gel | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 172 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 16, 2016 |
| Actual Primary Completion Date : | July 31, 2019 |
| Actual Study Completion Date : | October 25, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
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Drug: Acthar Gel
1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
Other Name: Repository corticotropin |
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Placebo Comparator: Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
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Drug: Placebo Gel
1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
Other Name: Matching placebo |
- 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.
- Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 20, Week 24 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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Have a documented history or screening result of
- positive antinuclear antibody (ANA), OR
- elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953821
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| Study Director: | Global Clinical Leader | Mallinckrodt |
| Responsible Party: | Mallinckrodt |
| ClinicalTrials.gov Identifier: | NCT02953821 |
| Other Study ID Numbers: |
MNK14304067 |
| First Posted: | November 3, 2016 Key Record Dates |
| Results First Posted: | August 20, 2020 |
| Last Update Posted: | August 20, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
Adrenocorticotropic Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |