Status:
COMPLETED
FLARE Lupus Research Study Systemic Lupus Erythematosus
Lead Sponsor:
Mymee Inc.
Conditions:
System; Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The first phase of this pilot study will assess changes in quality of life at the end of a 16-week Mymee program in patients with moderate to severe SLE. The second phase will assess changes in health...
Detailed Description
Intervention Group The Intervention Group will enter daily tasks into the Mymee app. After the first intake session, the subject will participate in weekly 20-30-minute coaching sessions with the Heal...
Eligibility Criteria
Inclusion
- ≥ 18 years of age who can consent for themselves
- Location - U.S.
- Proficient in English (speaking, reading, and writing)
- Own or have reliable access to a smartphone (iPhone or Android)
- Provision of medical record
- Diagnosis of Lupus SLE as indicated in medical record
- Symptomatic lupus as indicated by a score of at least 6 on one or more of BPI-SF questions 3, 5, or 6 and/or a score of at least 3 on one or more of the first four questions on the FACIT
- Current prescription for one or more of the following medications: 20mg/day of oral prednisone (or other oral corticosteroid equivalent dose); methotrexate and/or other immunosuppressive therapy of any dosage such as cyclophosphamide (Cytoxan®), methotrexate (Rheumatrex™), or azathioprine (muran®), adalimumab (Humira Pen, Humira Pen Crohn's-UC-HS Start, Humira Pediatric Crohn's Start, Humira, and Humira Pen Psoriasis-Uveitis), Plaquenil, Cellcept; monoclonal antibodies (mAbs) such as Benlysta® (belimuab, formerly called LymphoStat-B™); rituximab (Rituxan, MabThera and others);
- Able and willing to consent to study protocol
- Medications which have been stable for 3 months
Exclusion
- Pregnant and/or planning to get pregnant before end of 16-week intervention
- In prison during any part of the 16-month study period
- Resident of a nursing home, wards of the state, or Institutionalized during any part of the 16-month study period
- Persons with decisional incapacity/cognitive impairment
- Participating in another clinical trial, interventional or observational research during the study period
- Plan or intention to receive/start during the 16-week (112 day) intervention period either:
- a standing dose of oral steroid agents at a 20mg dose of prednisone (or other oral corticosteroid equivalent dose);
- pulses or tapers of steroids for flares for more than a total of 30 days within the observation period
- any pulse/taper dose of steroids during the last 4 weeks of the intervention period;
- immunosuppressive agents, or biologic response modifiers.
- Diagnosed with cancer
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03426384
Start Date
February 12 2018
End Date
December 5 2019
Last Update
December 10 2019
Active Locations (1)
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1
Mymee Inc.
New York, New York, United States, 11215