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

• Sponsor: Ampel BioSolutions, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03098823
• Collaborator: (none)
• Enrollment: 62
• Locations: 21
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual 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: Sep 12, 2017
• Actual Primary Completion Date: May 28, 2019
• Actual Study Completion Date: Jun 15, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Fatigue [3 months]

   Fatigue as measured in FACIT-F by patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• 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)

1. 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

2. 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

3. 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

1. History of noncompliance with taking pills as prescribed.

2. Rapidly progressive neurologic disease

3. 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)

4. Diagnosis of fibromyalgia

5. 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)

1. 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

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

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

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	The Regents of the University of California, Los Angeles	Los Angeles	California	United States	90095
3	University of California-Irvine	Orange	California	United States	92868
4	Stanford University	Palo Alto	California	United States	94304
5	The Regents of the University of California, San Diego	San Diego	California	United States	92037
6	University of California-San Francisco	San Francisco	California	United States	94143
7	Yale School of Medicine	New Haven	Connecticut	United States	06519
8	University of Florida College of Medicine	Gainesville	Florida	United States	32610
9	Miller School of Medicine at the University of Miami	Miami	Florida	United States	33136
10	Northwestern University	Chicago	Illinois	United States	60611
11	Rush University Medical Center	Chicago	Illinois	United States	60612
12	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
13	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
14	UMASS Memorial Medical Center-Memorial Campus	Worcester	Massachusetts	United States	01605
15	The Hospital for Special Surgery	New York	New York	United States	10021
16	Columbia University Medical Center	New York	New York	United States	10032
17	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
18	The MetroHealth System	Cleveland	Ohio	United States	44109
19	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
20	Hershey Medical Center	Hershey	Pennsylvania	United States	17033
21	Temple University	Philadelphia	Pennsylvania	United States	19140

Sponsors and Collaborators

• Ampel BioSolutions, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ampel BioSolutions, LLC
• ClinicalTrials.gov Identifier: NCT03098823
• Other Study ID Numbers: AMP-002
• First Posted: Apr 4, 2017
• Last Update Posted: Jul 8, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Fatigue; Prednisone

Study Results

No Results Posted as of Jul 8, 2020