A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE

Not Recruiting

Trial ID: NCT03098823


To compare the effect of RAYOS® versus immediate-release (IR) prednisone on fatigue as measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).

Official Title

A Randomized, Double-Blind, Active Comparator-Controlled, Crossover Study to Assess the Capacity of RAYOS® Compared to Immediate-Release Prednisone to Improve Fatigue and Control Morning Symptoms in Subjects With Systemic Lupus Erythematosus

Stanford Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS

Assistant Professor of Medicine (Immunology and Rheumatology)


Inclusion Criteria:

   1. Provide written informed consent agreeing to all study procedures, before any
   study-specific procedures are done.

   2. Males or non-pregnant females, aged 18 years or older

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

   4. Fatigue measured by FACIT-F ≤30.

   5. On a stable regimen of IR prednisone (5 to 15 mg/day) for a period of at least 30 days
   prior to Screening, expected to remain stable for the next 6 months.

   6. On a stable SLE treatment regimen for a period of at least 30 days prior to Screening,
   and expected to remain stable for the next 6 months. Any of the following medications
   are permitted if stable for at least 30 days prior to Screening and expected to remain
   stable for the next 6 months:

      - Hydroxychloroquine or equivalent anti-malarial

      - Other immunosuppressive or immunomodulatory agents including methotrexate,
      azathioprine, leflunomide, mycophenolate (including mycophenolate sodium or
      mycophenylate mofetil at no more than 2 grams/day), belimumab, cyclophosphamide,
      calcineurin inhibitors (e.g. tacrolimus, cyclosporine)

   7. Entry of daily ePRO data on 11 of 14 days during the baseline period, and completion
   of at least 6 out of the 8 weekly ePRO questionnaires during the baseline period

   8. Willing and able to perform and comply with all study procedures, including taking
   pills daily as prescribed, completing the ePROs on the smart phone, wearing the smart
   watch day and night, bringing the smartphone on all activities away from home (e.g.,
   walks, errands, visiting, shopping, traveling), keeping the smartphone and smartwatch
   charged daily, carefully using the smartphone and smartwatch as clinical tools and
   keeping them secure from others, and attending monthly clinic visits as scheduled

   9. Females of childbearing potential must be currently using a highly effective method of
   contraception that may include, but is not limited to, abstinence, sex only with
   persons of the same sex, monogamous relationship with vasectomized partner,
   hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine
   device, or use of a spermicide combined with a barrier method (e.g., condom,
   diaphragm) for 30 days before and 90 days after receiving the study drug

Exclusion Criteria:

   1. Previously taken any of the following medications:

      - RAYOS®

      - Rituximab within 6 months prior to Screening

      - Any investigational therapy within 3 months or 5 half-lives of the agent prior to

   2. History of noncompliance with taking pills as prescribed.

   3. Rapidly progressive neurologic disease

   4. Rapidly progressive renal disease (defined by proteinuria >6 g/24 hours or equivalent
   using spot urine protein to creatinine ratio, or serum creatinine >2.5 mg/dL)

   5. Diagnosis of fibromyalgia

   6. Any of the following clinical laboratory abnormalities:

      - Hemoglobin <8.0 mg/dL

      - Platelet count <50,000/mm3

      - White blood count (WBC) ≤ 2000/mm3; may be 1999-1000/mm3 if stable and related to

      - Absolute neutrophil count (ANC) ≤1000/mm3; may be 500-999/mm3 if stable and
      related to SLE

      - Aspartate transaminase (AST) or alanine transaminase (ALT) ≥3× upper limit of
      normal (ULN) unless related to SLE

      - Calculated creatinine clearance ≤25 mL/min per 1.73 m2 (by Cockcroft-Gault

   7. Grade 3 or greater laboratory abnormality based on the National Cancer Institute
   Common Terminology Criteria for Adverse Events (CTCAE; Appendix 3) except for the
   following that are allowed:

      - Activated partial thromboplastin time (PTT) > >2.5× ULN due to lupus
      anticoagulant and not related to liver disease or anti-coagulant therapy

      - Hypoalbuminemia <2 g/dL due to chronic lupus nephritis, and not related to liver

      - Gamma glutamyl transferase (GGT) <20× ULN due to lupus hepatitis, and not related
      to alcoholic liver disease, uncontrolled diabetes, or viral hepatitis. If
      present, any abnormalities in the ALT and/or AST must be ≤5× ULN

   8. Pregnant or nursing, or females not using effective contraception

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

10. 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


drug: RAYOS

drug: Prednisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mark Genovese