Hydroxychloroquine in Systemic Lupus Erythematosus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03802188|
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
|Condition or disease|
|Systemic Lupus Erythematosus|
|Study Type :||Observational|
|Estimated Enrollment :||3700 participants|
|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|
Investigators will use existing data collected on adult SLE patients enrolled into respective study cohorts from participating centers.
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.
- 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.
- 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.
- 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).
- 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.
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
|Contact: Jennifer Lee||514-934-1934 ext 44830||Jennifer.Lee@rimuhc.ca|
|Contact: Autumn Neville||514-934-1934 ext email@example.com|
|Research Institute of the McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada, H3H 2R9|
|Principal Investigator:||Sasha Bernatsky, MD/PhD||Research Institute of the McGill University Health Centre|