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Completed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT03098823

Public ClinicalTrials.gov record NCT03098823. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 1:10 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03098823
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Ampel BioSolutions, LLC
Industry
Enrollment
62 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 12, 2017 (Actual)
Primary completion
May 28, 2019 (Actual)
Completion
Jun 15, 2020 (Actual)
Last update posted
Jul 8, 2020

2017 – 2020

United States locations

U.S. sites
21
U.S. states
11
U.S. cities
18
Facility City State ZIP Site status
Cedars-Sinai Medical Center Los Angeles California 90048 —
The Regents of the University of California, Los Angeles Los Angeles California 90095 —
University of California-Irvine Orange California 92868 —
Stanford University Palo Alto California 94304 —
The Regents of the University of California, San Diego San Diego California 92037 —
University of California-San Francisco San Francisco California 94143 —
Yale School of Medicine New Haven Connecticut 06519 —
University of Florida College of Medicine Gainesville Florida 32610 —
Miller School of Medicine at the University of Miami Miami Florida 33136 —
Northwestern University Chicago Illinois 60611 —
Rush University Medical Center Chicago Illinois 60612 —
University of Maryland School of Medicine Baltimore Maryland 21201 —
Massachusetts General Hospital Boston Massachusetts 02114 —
UMASS Memorial Medical Center-Memorial Campus Worcester Massachusetts 01605 —
The Hospital for Special Surgery New York New York 10021 —
Columbia University Medical Center New York New York 10032 —
University of North Carolina at Chapel Hill Chapel Hill North Carolina 27599 —
The MetroHealth System Cleveland Ohio 44109 —
Oklahoma Medical Research Foundation Oklahoma City Oklahoma 73104 —
Hershey Medical Center Hershey Pennsylvania 17033 —
Temple University Philadelphia Pennsylvania 19140 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03098823, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 8, 2020 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03098823 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →