deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03098823

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

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

Sponsor: Ampel BioSolutions, LLC

Interventions Prednisone RAYOS
Updated 11 times since 2017 Last updated: Jul 7, 2020 Started: Sep 12, 2017 Primary completion: May 28, 2019 Completion: Jun 15, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Fatigue and Lupus Erythematosus and is currently completed. Ampel BioSolutions, LLC leads this study, which shows 11 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~May 2017 – ~Jun 2017 · 31 days · monthly snapshotRecruiting~Jun 2017 – ~Oct 2017 · 4 months · monthly snapshotRecruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotRecruiting~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshotRecruiting~Jul 2018 – ~Oct 2018 · 3 months · monthly snapshotRecruiting~Oct 2018 – ~Jan 2019 · 3 months · monthly snapshotRecruiting~Jan 2019 – ~Aug 2020 · 19 months · monthly snapshotActive Not Recruiting~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Aug 2020 — Jan 2021 [monthly]

    Completed PHASE4

    Status: Active Not RecruitingCompleted

  5. Jan 2019 — Aug 2020 [monthly]

    Active Not Recruiting PHASE4

    Status: RecruitingActive Not Recruiting

Show 6 earlier versions
  1. Oct 2018 — Jan 2019 [monthly]

    Recruiting PHASE4

  2. Jul 2018 — Oct 2018 [monthly]

    Recruiting PHASE4

  3. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE4

  4. Oct 2017 — Jun 2018 [monthly]

    Recruiting PHASE4

  5. Jun 2017 — Oct 2017 [monthly]

    Recruiting PHASE4

  6. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Ampel BioSolutions, LLC
Data source: Ampel BioSolutions, LLC

For direct contact, visit the study record on ClinicalTrials.gov .