FLARE Lupus Research Study Systemic Lupus Erythematosus

Completed · Not applicable

Conditions studied: System; Lupus Erythematosus

In brief

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 healthcare utilization and cost over a one year period after program end.

Key facts

Study ID

NCT03426384

Run by

Mymee Inc.

People needed

50

Starts

2018-02-12

Expected to finish

2019-12-05

Last updated by the study team

2019-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Mymee Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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