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Hydroxychloroquine in Systemic Lupus Erythematosus

NCT03802188 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3700

Last updated 2019-01-14

No results posted yet for this study

Summary

A Systemic lupus erythematosus, SLE is disease in which immune system is over-active causing inflammation in joints skin or any organ system. There are many areas where better approaches in SLE could improve outcomes. One example relates to hydroxychloroquine (HCQ) key drug which can reduce risk of serious disease flares. There are increasing concerns about eye damage main side effect with long-term use of HCQ. At present investigators cannot precisely predict which SLE patient is most likely to flare once HCQ is tapered. It is not clear what drives risk of eye damage. Investigators' study will fill these knowledge gaps. Investigators' hypothesis is that baseline demographic and clinical factors are associated with risk of SLE flare after HCQ taper/discontinuation and with risk of retinal toxicity in all HCQ exposed patients. Research will link and analyze data on 3700 SLE patients across Canada.

Conditions

Sponsors & Collaborators

  • Laval University

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • University of Manitoba

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Sasha Bernatsky, MD/PhD · Research Institute of the McGill University Health Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2024-03-31
Completion
2025-03-31

Countries

  • Canada

Study Locations

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Entities

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 NCT03802188 on ClinicalTrials.gov