Acthar SLE (Systemic Lupus Erythematosus) (Acthar SLE)
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|ClinicalTrials.gov Identifier: NCT02779153|
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus (SLE) Repository Corticotropin Injection||Drug: Acthar low dose (40 U) Drug: Acthar high dose (80 U)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy, Safety, and Steroid Sparing Effect of Acthar in Patients With Hematologic Manifestations of Systemic Lupus Erythematosus|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
|Experimental: Acthar low dose (40 U)||
Drug: Acthar low dose (40 U)
The 40U group will administer 0.5 mL of study medication once a day. Patients will taper study medication during Week 2 through the remainder of the study and will administer 0.5 mL of study medication twice a week. The stable Acthar regimen should be maintained for the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Other Name: Repository Corticotropin Injection
|Experimental: Acthar high dose (80 U)||
Drug: Acthar high dose (80 U)
The 80U group will administer 1.0 mL of study medication every day. If a patient meets dose reduction criteria, their assigned volume will be adjusted from 1.0 mL to 0.5 mL. Patients will taper study medication during Week 2 through the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
Other Name: Repository Corticotropin Injection
- Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score [ Time Frame: Baseline to Week 24 ]Disease activity is based on 24 questions, weighted across nine organ systems, combined into a total score that can range from 0 to 105, but are generally < 20, even with very active disease.
- British Isles Lupus Assessment Group (BILAG) disease activity index Score [ Time Frame: Baseline to Week 24 ]Items are rated as 0 (not present), 1 (improving), 2 (same), 3 (worse), or 4 (new) in the last 4 weeks compared with the previous 4 weeks. The numerical scores are used to categorize each organ system by an alphabetical score: 'A' reflecting severe disease requiring increases in prednisone to > 20 mg daily and/or addition of immunosuppressive agents, 'B' indicated less active disease, requiring low-dose prednisone and/or symptomatic treatment with NSAIDs and/or antimalarials, 'C' reflecting mild disease requiring only symptomatic therapy, 'D' reflecting previous organ system involvement without current disease activity, and 'E' reflecting no prior or no current disease involvement in that organ system.
- Physician's Global Assessment Score [ Time Frame: Baseline to Week 24 ]The Physician's Global Assessment is a 10 cm visual analogue scale (VAS) anchored at 0 (none) and 3 (severe) with intermediate lines at 1 (mild) and 2 (moderate). It is designed for the physician to indicate the patient's overall disease activity at a particular visit
- SELENA Flare Index Score [ Time Frame: Baseline to Week 24 ]
The SELENA Flare Index categorizes SLE flare as 'mild or moderate' or 'severe' based on six variables
- Change in SLEDAI score from the most recent assessment to current.
- Change in signs or symptoms of disease activity.
- Change in prednisone dosage.
- Use of new medication for disease activity or hospitalization.
- Change in PGA score.
- Hospitalization for SLE activity (severe flare only).
- SLICC/ACR Damage Index [ Time Frame: Baseline to Week 24 ]The SLICC/ACR Damage Index measures irreversible organ damage from either the disease process or treatment, which has been present for ≥ 6 months, in 12 organ systems. It is an important predictor of long-term mortality and is an independent outcome measure separate from the SLEDAI.
- Medical Outcomes Survey Short Form-36 [ Time Frame: Baseline to Week 24 ]The SF-36 has been validated in SLE and includes eight domains: physical functioning, role physical, bodily pain, general health perceptions, vitality (which includes fatigue, energy and vigor), social functioning, role emotional and mental-health impact, combined into two summary scores (physical component summary scores [PCS] and mental component summary scores [MCS])
- FACIT Fatigue Scale [ Time Frame: Baseline to Week 24 ]The FACIT-F scale is a 13-item questionnaire to evaluate self-reported fatigue and its impact upon daily activities and function. The responses are measured on a 4-point Likert scale, with the total score ranging from 0 to 52. The FACIT-F scale has been validated in SLE patients.
- Patient's Global Assessment [ Time Frame: Baseline to Week 24 ]Subjects rate their global assessment of SLE disease activity on each visit, in response to the question "Considering all the ways your SLE affects you, please mark a vertical line on the scale below for how are you feeling today?" using a 100mm visual analogue scale, where 0 is "very good, no symptoms" and 100 is "very poor, very severe symptoms."
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): NCT02779153
|Contact: Hannah Bernsteinfirstname.lastname@example.org|
|United States, New York|
|New York University School of Medicine||Recruiting|
|New York, New York, United States, 10016|
|Contact: Hannah Bernstein email@example.com|
|Principal Investigator: Amit Saxena, MS|
|Sub-Investigator: Janine Sullivan, MD|
|Sub-Investigator: Jill Buyon, MD|
|Principal Investigator:||Amit Saxena, MD||New York University Medical School|