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Hydroxychloroquine in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03802188
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Laval University
University of British Columbia
University of Calgary
Dalhousie University
University of Manitoba
University of Toronto
University of Alberta
Information provided by (Responsible Party):
Dr. Sasha Bernatsky, McGill University Health Center

Brief 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.

Condition or disease
Systemic Lupus Erythematosus

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Hydroxychloroquine Exposure in Systemic Lupus Erythematosus (SLE)
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Group/Cohort
SLE Cohort
Investigators will use existing data collected on adult SLE patients enrolled into respective study cohorts from participating centers.
Qualitative group
For the interviews, patients with SLE who are currently or have taken Hydroxychloroquine will be recruited from rheumatology clinics in Calgary and Montreal to participate in an interview and/or participate in a brief survey.



Primary Outcome Measures :
  1. Proportion of SLE flares with decrease or discontinuation of HCQ [ Time Frame: Through study completion, an average of 1 year ]
    In patients exposed to HCQ, presence or absence of SLE flare will be measure with SLEDAI-2K. The SLEDAI-2K is a reliable, validated, widely used global score index, consisting of 24 weighted clinical and laboratory variables of nine organ systems. The scores of descriptors range from 1 to 8, and the total score of the SLEDAI-2K is the sum of all 24 descriptor scores. An increase of 4 points or more has been validated as indicating a clinically significant increase in SLE disease activity.


Secondary Outcome Measures :
  1. Proportion of participants hospitalized with decrease or discontinuation of HCQ [ Time Frame: Through study completion, an average of 1 year ]
    In patients exposed to HCQ, presence or absence of hospitalization in cohort data will be measured in relation to HCQ dosage.

  2. Proportion of SLE flares relative to augmented SLE therapy [ Time Frame: Through study completion, an average of 1 year ]
    Comparison of flares in SLE patients measured with SLEDAI-2K and augmented SLE therapy defined as an increase in HCQ or a new start or increase in corticosteroids (i.e. prednisone, methylprednisolone) or other immunosuppressant (azathioprine, mycophenolate, methotrexate, cyclophosphamide, belimumab, rituximab, chloroquine).

  3. Correlation of retinal toxicity and exposure to HCQ and retinal toxicity [ Time Frame: Through study completion, an average of 1 year ]
    Renal damage is captured with the SLICC Damage Index, measuring accumulated damage since SLE onset. This validated index captures irreversible change in an organ or system (that has been present for at least 6 months). The renal item scores 1 for sustained heavy proteinuria, 2 for reduced glomerular filtration rate, and 3 for end-stage renal failure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators will use existing data collected on adult SLE patients who have been consecutively enrolled into the respective study cohorts of the participating researchers in Montreal , Quebec City, Halifax, Winnipeg, Calgary, and Toronto. The total exceeds 3,300 SLE patients who have been exposed to HCQ.
Criteria

Inclusion Criteria:

  • Must be 18 years of age or over
  • Must be diagnosed with Systemic Lupus Erythematosus (SLE)
  • Must be exposed to hydroxychloroquine
  • Must be enrolled at participating sites

Exclusion Criteria:

  • Under 18 years of age
  • Not diagnosed with SLE
  • Not exposed to hydroxychloroquine
  • Not enrolled at participating sites

Information from the National Library of Medicine

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): NCT03802188


Contacts
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Contact: Jennifer Lee 514-934-1934 ext 44830 Jennifer.Lee@rimuhc.ca
Contact: Autumn Neville 514-934-1934 ext 44844 autumn.neville@rimuch.ca

Locations
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Canada, Quebec
Research Institute of the McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3H 2R9
Sponsors and Collaborators
McGill University Health Center
Laval University
University of British Columbia
University of Calgary
Dalhousie University
University of Manitoba
University of Toronto
University of Alberta
Investigators
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Principal Investigator: Sasha Bernatsky, MD/PhD Research Institute of the McGill University Health Centre

Additional Information:
Publications of Results:

Other Publications:

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Responsible Party: Dr. Sasha Bernatsky, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03802188     History of Changes
Other Study ID Numbers: MP-37-2019-4340
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Sasha Bernatsky, McGill University Health Center:
Retinal toxicity

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents