Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC)
Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus (SLE), an autoimmune disease
Eligibility Criteria
Inclusion Criteria:
Age > 18 years old.
SLE with ≥ 4 of eleven diagnostic criteria approved by the American College of Rheumatology
Stable immunosuppressants (MMF ≤ 3 g/day, azathioprine ≤ 100 mg/day; methotrexate ≤ 15 mg/day) and/or antimalarials (hydroxychloroquine ≤ 400 mg/day) for 30 days prior to screening; stable oral corticosteroids for 2 weeks prior to screening; ≤ 20 mg/day prednisone or equivalent; stable belimumab for 90 days prior to screening;
BILAG 2004 index level A disease activity in ≥ 1 organ/system except renal or central nervous system or (ii) BILAG 2004 index level B disease activity in ≥ 2 organs/systems if no level A disease activity is present and (iii) SLEDAI ≥ 6;
Exclusion Criteria:
Acute flare of SLE threatening vital organs and requiring intravenous
Pregnant or lactating
Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency)
Patients receiving cyclophosphamide within 3 months
Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patient with oral steroid-dependent asthma;
Infections requiring intravenous antibiotics within a month or oral antibiotics within two weeks of screening; Patients taking (unwilling or unable to stop) NAC or other antioxidants within 1 month of screening
Patients who participated in the pilot RCT or are taking daily acetaminophen (</= 1 g/day PRN is allowed if documented)
Patients receiving rituximab within 12 months or other biologic therapy within five half-lives
Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus)
Patients enrolled in other interventional trials
Healthy subjects serve as controls for in vitro immunological studies
Sites / Locations
- SUNY Upstate Medical UniversityRecruiting
- SUNY Upstate Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
NAC
Placebo
2.4 g - 4.8 g of NAC daily starting after 3 month open label titration period.
2.4 g - 4.8 g of placebo per day after 3 month open label titration period.