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

NCT03098823 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-07-08

No results posted yet for this study

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).

Conditions

  • Lupus Erythematosus, Systemic
  • Lupus Erythematosus
  • Fatigue

Interventions

DRUG

RAYOS

FDA approved RAYOS for indication of fatigue in Lupus.

DRUG

Prednisone

FDA approved corticosteroid frequently used for SLE.

Sponsors & Collaborators

  • Ampel BioSolutions, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2019-05-28
Completion
2020-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03098823 on ClinicalTrials.gov