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

Description

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).

Study Start Date

September, 12 2017

Estimated Completion Date

June 2018

Interventions

  • Drug: Prednisone
  • Drug: RAYOS

Study ID

Ampel BioSolutions, LLC -- AMP-002

Status

Recruiting

Trial ID

NCT03098823

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

62

Sponsor

Ampel BioSolutions, LLC

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

Gender

All

Ages

18 Years to 99 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (63)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles John Stone 617-724-7732 jhstone@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles John Stone 617-724-7732 jhstone@mgh.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles John Stone 617-724-7732 jhstone@mgh.harvard.edu
UMASS Memorial Medical CenterMemorial Campus - Worcester, Massachusetts 35.9 miles Jonathon Kay 508-334-6273 jonathon.kay@umassmemorial.org
UMASS Memorial Medical CenterMemorial Campus - Worcester, Massachusetts 35.9 miles Jonathon Kay 508-334-6273 jonathon.kay@umassmemorial.org
UMASS Memorial Medical CenterMemorial Campus - Worcester, Massachusetts 35.9 miles Jonathon Kay 508-334-6273 jonathon.kay@umassmemorial.org
Yale School of Medicine - New Haven, Connecticut 120.2 miles Fotios Koumpouras 203-785-2454 fotios.koumpouras@yale.edu
Yale School of Medicine - New Haven, Connecticut 120.2 miles Fotios Koumpouras 203-785-2454 fotios.koumpouras@yale.edu
Yale School of Medicine - New Haven, Connecticut 120.2 miles Fotios Koumpouras 203-785-2454 fotios.koumpouras@yale.edu
Columbia University Medical Center - New York, New York 181.2 miles Anca Askanase 212-305-0856 ada20@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Anca Askanase 212-305-0856 ada20@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Anca Askanase 212-305-0856 ada20@cumc.columbia.edu
The Hospital for Special Surgery - New York, New York 184.8 miles Kyriakos Kirou 212-606-1728 kirouk@hss.edu
The Hospital for Special Surgery - New York, New York 184.8 miles Kyriakos Kirou 212-606-1728 kirouk@hss.edu
The Hospital for Special Surgery - New York, New York 184.8 miles Kyriakos Kirou 212-606-1728 kirouk@hss.edu
Temple University - Philadelphia, Pennsylvania 266.2 miles Robert Caricchio None roc@temple.edu
Temple University - Philadelphia, Pennsylvania 266.2 miles Robert Caricchio None roc@temple.edu
Temple University - Philadelphia, Pennsylvania 266.2 miles Robert Caricchio None roc@temple.edu
Hershey Medical Center - Hershey, Pennsylvania 321.7 miles Nancy Olsen 717-531-4921 nolsen@pennstatehealth.psu.edu
Hershey Medical Center - Hershey, Pennsylvania 321.7 miles Nancy Olsen 717-531-4921 nolsen@pennstatehealth.psu.edu
Hershey Medical Center - Hershey, Pennsylvania 321.7 miles Nancy Olsen 717-531-4921 nolsen@pennstatehealth.psu.edu
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Violeta Rus 410-706-3205 vrus@umaryland.edu
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Violeta Rus 410-706-3205 vrus@umaryland.edu
University of Maryland School of Medicine - Baltimore, Maryland 358.9 miles Violeta Rus 410-706-3205 vrus@umaryland.edu
The MetroHealth System - Cleveland, Ohio 549.6 miles Stanley Ballou 216-778-5846 sballou@metrohealth.org
The MetroHealth System - Cleveland, Ohio 549.6 miles Stanley Ballou 216-778-5846 sballou@metrohealth.org
The MetroHealth System - Cleveland, Ohio 549.6 miles Stanley Ballou 216-778-5846 sballou@metrohealth.org
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles Saira Sheikh 919-966-0576 szsheikh@email.unc.edu
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles Saira Sheikh 919-966-0576 szsheikh@email.unc.edu
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles Saira Sheikh 919-966-0576 szsheikh@email.unc.edu
Northwestern University - Chicago, Illinois 847.9 miles Mary Mahieu 312-503-1919 mary-mahieu@northwestern.edu
Northwestern University - Chicago, Illinois 847.9 miles Mary Mahieu 312-503-1919 mary-mahieu@northwestern.edu
Northwestern University - Chicago, Illinois 847.9 miles Mary Mahieu 312-503-1919 mary-mahieu@northwestern.edu
Rush University Medical Center - Chicago, Illinois 851.3 miles Meenakshi Jolly 312-563-2800 meenakshi_jolly@rush.edu
Rush University Medical Center - Chicago, Illinois 851.3 miles Meenakshi Jolly 312-563-2800 meenakshi_jolly@rush.edu
Rush University Medical Center - Chicago, Illinois 851.3 miles Meenakshi Jolly 312-563-2800 meenakshi_jolly@rush.edu
University of Florida College of Medicine - Gainesville, Florida 1,081.3 miles Michael Bubb 352-294-8203 bubbmr@medicine.ufl.edu
University of Florida College of Medicine - Gainesville, Florida 1,081.3 miles Michael Bubb 352-294-8203 bubbmr@medicine.ufl.edu
University of Florida College of Medicine - Gainesville, Florida 1,081.3 miles Michael Bubb 352-294-8203 bubbmr@medicine.ufl.edu
Miller School of Medicine at the University of Miami - Miami, Florida 1,259.8 miles Maria Carpintero 305-243-0151 mcarpintero@med.miami.edu
Miller School of Medicine at the University of Miami - Miami, Florida 1,259.8 miles Maria Carpintero 305-243-0151 mcarpintero@med.miami.edu
Miller School of Medicine at the University of Miami - Miami, Florida 1,259.8 miles Maria Carpintero 305-243-0151 mcarpintero@med.miami.edu
Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma 1,493.6 miles Katherine Thanou 405-271-7805 katherine-thanou@omrf.org
Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma 1,493.6 miles Katherine Thanou 405-271-7805 katherine-thanou@omrf.org
Oklahoma Medical Research Foundation - Oklahoma City, Oklahoma 1,493.6 miles Katherine Thanou 405-271-7805 katherine-thanou@omrf.org
The Regents of the University of California San Diego - San Diego, California 2,583.7 miles Kenneth Kalunian 858-657-7049 kkalunian@ucsd.edu
The Regents of the University of California San Diego - San Diego, California 2,583.7 miles Kenneth Kalunian 858-657-7049 kkalunian@ucsd.edu
The Regents of the University of California San Diego - San Diego, California 2,583.7 miles Kenneth Kalunian 858-657-7049 kkalunian@ucsd.edu
University of CaliforniaIrvine - Orange, California 2,585.0 miles Sheetal Desai 714-456-5135 sheetald@uci.edu
University of CaliforniaIrvine - Orange, California 2,585.0 miles Sheetal Desai 714-456-5135 sheetald@uci.edu
University of CaliforniaIrvine - Orange, California 2,585.0 miles Sheetal Desai 714-456-5135 sheetald@uci.edu
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Daniel Wallace None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Daniel Wallace None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Daniel Wallace None None
The Regents of the University of California Los Angeles - Los Angeles, California 2,605.2 miles Maureen McMahon 310-825-9447 mmcmahon@mednet.ucla.edu
The Regents of the University of California Los Angeles - Los Angeles, California 2,605.2 miles Maureen McMahon 310-825-9447 mmcmahon@mednet.ucla.edu
The Regents of the University of California Los Angeles - Los Angeles, California 2,605.2 miles Maureen McMahon 310-825-9447 mmcmahon@mednet.ucla.edu
Stanford University - Palo Alto, California 2,694.6 miles Mark Genovese 650-498-5630 genovese@stanford.edu
Stanford University - Palo Alto, California 2,694.6 miles Mark Genovese 650-498-5630 genovese@stanford.edu
Stanford University - Palo Alto, California 2,694.6 miles Mark Genovese 650-498-5630 genovese@stanford.edu
University of CaliforniaSan Francisco - San Francisco, California 2,699.8 miles Maria DallEra 415-502-1886 maria.dallera@ucsf.edu
University of CaliforniaSan Francisco - San Francisco, California 2,699.8 miles Maria DallEra 415-502-1886 maria.dallera@ucsf.edu
University of CaliforniaSan Francisco - San Francisco, California 2,699.8 miles Maria DallEra 415-502-1886 maria.dallera@ucsf.edu

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