Clinical trial NCT03098823: A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lupus Erythematosus, Systemic
Lupus Erythematosus
Fatigue
Lead sponsor: Ampel BioSolutions, LLC
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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 Screening
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 SLE
   * 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 equation)
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 disease
   * 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

Primary outcomes:
measure: Fatigue
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: The Regents of the University of California, Los Angeles
state: California
city: Orange
country: United States
facility: University of California-Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: The Regents of the University of California, San Diego
state: California
city: San Francisco
country: United States
facility: University of California-San Francisco
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Miami
country: United States
facility: Miller School of Medicine at the University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center-Memorial Campus
state: Massachusetts
city: New York
country: United States
facility: The Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References: