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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03098823
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : September 6, 2018
Information provided by (Responsible Party):
Ampel BioSolutions, LLC

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).

Condition or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Lupus Erythematosus Fatigue Drug: RAYOS Drug: Prednisone Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: RAYOS® Drug: RAYOS
FDA approved RAYOS for indication of fatigue in Lupus.

Active Comparator: IR prednisone Drug: Prednisone
FDA approved corticosteroid frequently used for SLE.

Primary Outcome Measures :
  1. Fatigue [ Time Frame: 3 months ]
    Fatigue as measured in FACIT-F by patient

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03098823

Contact: Claire Dykas 434-477-2675

United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Daniel Wallace         
The Regents of the University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Maureen McMahon    310-825-9447   
University of California-Irvine Recruiting
Orange, California, United States, 92868
Contact: Sheetal Desai    714-456-5135   
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Mark Genovese    650-498-5630   
The Regents of the University of California, San Diego Recruiting
San Diego, California, United States, 92037
Contact: Kenneth Kalunian    858-657-7049   
University of California-San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Maria Dall'Era    415-502-1886   
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06519
Contact: Fotios Koumpouras    203-785-2454   
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32610
Contact: Michael Bubb    352-294-8203   
Miller School of Medicine at the University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Maria Carpintero    305-243-0151   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Mary Mahieu    312-503-1919   
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Meenakshi Jolly    312-563-2800   
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Violeta Rus    410-706-3205   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: John Stone    617-724-7732   
UMASS Memorial Medical Center-Memorial Campus Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Jonathon Kay    508-334-6273   
United States, New York
The Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Kyriakos Kirou    212-606-1728   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Anca Askanase    212-305-0856   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Saira Sheikh    919-966-0576   
United States, Ohio
The MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Stanley Ballou    216-778-5846   
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Cristina Arriens   
United States, Pennsylvania
Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Nancy Olsen    717-531-4921   
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Robert Caricchio   
Sponsors and Collaborators
Ampel BioSolutions, LLC

Responsible Party: Ampel BioSolutions, LLC Identifier: NCT03098823     History of Changes
Other Study ID Numbers: AMP-002
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Signs and Symptoms
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents