Recruiting

Observational Study

Sponsor:

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

Code:

NCT03802188

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT03802188

Start date

May 9, 2018

Status verified date

Jan, 2019

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3700 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Proportion of SLE flares with decrease or discontinuation of HCQ [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Jennifer Lee

514-934-1934Jennifer.Lee@rimuhc.ca

Autumn Neville

514-934-1934autumn.neville@rimuch.ca

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3H 2R9

More Information

Sponsor

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

Last update posted

Jan 14, 2019

Last verified

Jan, 2019

Keywords

  • Retinal toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-01-14.