A Crossover Study to Compare RAYOS to IR Prednisone to Improve Fatigue and Morning Symptoms for SLE (RIFLE)
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|ClinicalTrials.gov Identifier: NCT03098823|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lupus Erythematosus, Systemic Lupus Erythematosus Fatigue||Drug: RAYOS Drug: Prednisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||September 12, 2017|
|Actual Primary Completion Date :||May 28, 2019|
|Actual Study Completion Date :||June 15, 2020|
FDA approved RAYOS for indication of fatigue in Lupus.
|Active Comparator: IR prednisone||
FDA approved corticosteroid frequently used for SLE.
- Fatigue [ Time Frame: 3 months ]Fatigue as measured in FACIT-F by patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098823