Trial · Interventional
WithdrawnPhase 4Registry dataActhar SLE (Systemic Lupus Erythematosus)
Short name Acthar SLE
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: closed in agreement of the sponsor and institution due to lack of patient accrual.
Overview
- Status
- Withdrawn
- Phase
- Phase 4
- Enrollment
- 0 participants (actual)
- Sponsor
- NYU Langone Health · Other
- Design
- Randomized · Open label (no masking)
- Countries
- Not stated
- Start
- Oct 2016
- Primary completion
- 22 May 2019
- Completion
- 22 May 2019
- First posted
- 20 May 2016 (estimated)
- Last update posted
- 13 Sept 2019
- Conditions
- Systemic Lupus Erythematosus (SLE) · Repository Corticotropin Injection
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a randomized study exploring the efficacy, safety and steroid sparing ability of two doses (40 U and 80 U) of Acthar in SLE patients with immune mediated hematologic manifestations requiring steroid use for a minimum of 2 weeks prior to screening.
Interventions
- Acthar low dose (40 U)Drug
- Acthar high dose (80 U)Drug
Arms2
Experimental
Acthar low dose (40 U)
Experimental
Acthar high dose (80 U)
Primary outcomes5
Outcomes the sponsor listed as primary.
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score
Time frame · Baseline to Week 24
Registry description
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
Registry description
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
Registry description
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
Registry description
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
Registry description
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.
Secondary outcomes(3)
Medical Outcomes Survey Short Form-36
Time frame · Baseline to Week 24
Registry description
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
Registry description
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
Registry description
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."
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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