Validation of a Mobile Phone Based on EPRO Tool in Subjects With Systemic Lupus Erythematosus

Status:	Completed
Conditions:	Lupus
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	12/5/2018
Start Date:	August 21, 2017
End Date:	July 3, 2018

Systemic lupus erythematosus (SLE) may involve a variety of organ systems expressed
differently from patient to patient, and so can be difficult to characterize clinically.
Patient reported outcomes (PROs), which consist of feedback directly from patients regarding
their symptoms without interpretation by a clinician, are typically used in SLE to supplement
other clinical measures. Standard PROs typically used in SLE include the 36-item short form
health survey (SF-36), the functional assessment of chronic illness therapy - fatigue
(FACIT-F), and the patient global assessment (PtGA), administered by paper or electronic
tablet during the clinic visits. The recent development of electronic mobile device
technology, such as the smartphone, has made it possible to collect PRO information away from
the clinical site in the subject's environment. This study will assess by measurement
equivalence testing whether data collected via a smartphone are comparable to that collected
in standard fashion and whether PROs obtained in the subject's environment may be more
informative than that collected in the physician's office on paper.

Inclusion Criteria:

1. Willing and able to provide written informed consent

2. Males or females, aged 18 years or older

3. Classification of SLE by either the American College of Rheumatology (ACR) or Systemic
Lupus International Collaborating Clinics Classification (SLICC) criteria

4. On a stable SLE treatment regimen consisting of any of the following medications for a
period of at least 30 days prior to Screening

- Corticosteroids (<30 mg prednisone or equivalent per day)

- Hydroxychloroquine or equivalent anti-malarial

- Other immunosuppressive or immunomodulatory agents including methotrexate,
azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil or
sodium), cyclophosphasmide, belimumab, calcineurin inhibitors (e.g. tacrolimus,
cyclosporine)

5. Willing to perform and comply with all study procedures, including attending clinic
visits at Baseline, Month 1, and Month 2 as scheduled

Exclusion Criteria:

1. Rapidly progressive neurologic disease

2. Cognitive dysfunction that might interfere with the capacity to use the ePRO device

3. Any condition that might in the investigator's opinion might preclude completion of
the study

4. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or
dependence within 1 year prior to Screening

5. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases
not caused by SLE (e.g., diabetes, cardiovascular, pulmonary, hematologic,
gastrointestinal, neurological, or infectious) which, in the opinion of the
Investigator, could confound the results of the study or put the subject at undue
risk.

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000