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

Fatigue Clinical Trial

— RIFLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098823
• Other study ID #: AMP-002
• Status: Completed
• Phase: Phase 4
• Start date: September 12, 2017
• Est. completion date: June 15, 2020

Study information

• Verified date: July 2020
• Source: Ampel BioSolutions, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 15, 2020
• Est. primary completion date: May 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Lupus Erythematosus
• Lupus Erythematosus, Systemic

Intervention

Drug:
• RAYOS
FDA approved RAYOS for indication of fatigue in Lupus.
• Prednisone
FDA approved corticosteroid frequently used for SLE.

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The MetroHealth System	Cleveland	Ohio
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	The Regents of the University of California, Los Angeles	Los Angeles	California
United States	Miller School of Medicine at the University of Miami	Miami	Florida
United States	Yale School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	The Hospital for Special Surgery	New York	New York
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma
United States	University of California-Irvine	Orange	California
United States	Stanford University	Palo Alto	California
United States	Temple University	Philadelphia	Pennsylvania
United States	The Regents of the University of California, San Diego	San Diego	California
United States	University of California-San Francisco	San Francisco	California
United States	UMASS Memorial Medical Center-Memorial Campus	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Ampel BioSolutions, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Fatigue as measured in FACIT-F by patient	3 months