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Site for A PHASE III, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, NON-INFERIORITY, MULTI-CENTER STUDY OF THE EFFECTS OF STOPPING HYDROXYCHLOROQUINE IN ELDERLY LUPUS DISEASE

This trial will address the safety of withdrawing hydroxychloroquine (HCQ) in patients with systemic lupus erythematous who are 60 years of age or older. In this older population the need for continuing HCQ is expected to decrease, since disease activity tends to be lower with advancing age. The study will determine how safe it is to discontinue HCQ in this population.

Participants will be in this study for about 1 year, during which time they will come to 7 visits in the research clinic. The first visit will take up to 2 hours and will include blood and urine sampling and completion of self-assessment questionnaires. Subsequent visits will take up to 1 hour. Participants will be randomized to receive either the active drug hydroxychloroquine or placebo. The treatment will be blinded to both the participant and the investigator. Diaries will be requested in which the participant keeps track of dosing of the study medication.

Yes
 

Nancy Olsen
Jamie Carter - at jcarter3@pennstatehealth.psu.edu or 717-531-4921
Medicine: Rheumatology (HERSHEY)
 

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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05799378
SITE00001380
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Inclusion Criteria:
Have a diagnosis of systemic lupus
Be treated with hydroxychloroquine for at least 7 years
60 years of age or older
stable disease without recent flares

Exclusion Criteria:
abnormal eye exam related to use of hydroxychloroquine
taking more than 5 mg/day prednisone
any signs of active lupus disease.
Infectious Diseases & Immune System, Arthritis & Rheumatic Diseases
Not applicable
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Location Contacts
Hershey, PA ,