Phase
Condition
Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus
Lupus
Treatment
Nicotinamide Riboside
Clinical Study ID
Ages 18-120 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
SLE subjects:
Female subjects 18 years or older who meets > 3 of 11 modified Am. Coll. ofRheumatology (ACR) (1997) Revised Criteria for SLE and mild/moderate diseaseactivity defined as an SLE Disease Activity Index 2000(SLEDAI 2K) between zero andless than or equal to 14 at screening;
If on glucocorticoids, the dose must be less than or equal to 20 mg daily and stablefor at least 4 weeks prior to screening;
If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine,dose must have been stable for the 12 weeks prior to screening. The max. alloweddoses - hydroxychloroquine 400 mg/day, chloroquine phosphate 500 mg/day andquinacrine 100 mg/day;
If on immunosuppressive drugs (methotrexate, azathioprine, mycophenolate mofetil,cyclosporine, tacrolimus); dose must have been stable for the 12 weeks prior toscreening
Subjects of childbearing potential must agree to practice effective birth controlfor the duration of the study;
Stated willingness to comply with all study procedures and availability for theduration of the study;
Agreement to adhere to Lifestyle Considerations throughout study duration;
Ability of subject to understand and the willingness to sign a written informedconsent document.
If on vitamin B3 or tryptophan supplementation at screening, willing to stop it atleast 6 weeks before the baseline visit.
Control subjects:
Female subjects 18 years or older
No history of autoimmune or inflammatory disease
If on vitamin B3 or tryptophan supplementation at screening, willing to stop it atleast 6 weeks before the blood draw visit.
Exclusion
EXCLUSION CRITERIA:
SLE Subjects:
Active renal or central nervous system disease or major renal or hepaticdysfunction;
Treatment with rituximab, belimumab or any other biologic agent within the 6 monthsprior to screening
Treatment with cyclophosphamide or IVIG within the 6 months prior to screening andor increase in glucocorticoid dose within 4 weeks of screening;
Pregnancy or lactation (nursing)
Treatment with another investigational drug or other intervention within 6 months ofscreening
Control Subjects:
Inability to sign consent
Pregnancy or nursing
Pregnant women are excluded from participation on this study. Self-reported pregnancy status may be accepted from female control participants of child-bearing potential for a blood draw which is considered a minimal risk procedure.
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesSite Not Available
National Institutes of Health Clinical Center
Bethesda 4348599, Maryland 4361885 20892
United StatesActive - Recruiting

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