Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

Launched by STATE UNIVERSITY OF NEW YORK - UPSTATE MEDICAL UNIVERSITY · Oct 17, 2008

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a medication called N-acetylcysteine (NAC) to treat Systemic Lupus Erythematosus (SLE), a long-term disease that causes inflammation and can affect various parts of the body. The researchers want to see if NAC can help improve symptoms of SLE while being safe for patients. The trial will include adults over 18 years old who have been diagnosed with SLE and meet specific criteria. To participate, patients must have stable doses of certain medications for at least a month and not be experiencing a severe flare-up of their lupus.

Participants in the trial can expect to be part of the study for about 13 months, during which they will attend up to seven visits. Initially, they will take NAC for three months while researchers find the right dose for them. After this period, participants will be randomly assigned to either continue taking NAC or switch to a placebo (a sugar pill with no active ingredients). Throughout the study, participants will provide blood samples to help researchers understand how NAC affects their condition. If you're interested in joining, you'll need to sign a consent form to ensure you understand the details of the study and what it involves.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18;
• • Male or female;
• • ≥ 4 ACR SLE classification criteria (104,105);
• • Positive ANA at a titer of ≥ 1/80;
• • Stable immunosuppressants (MMF ≤ 3 g/day, azathioprine ≤ 150 mg/day; methotrexate ≤ 25 mg/week; leflunomide ≤ 20 mg/week; cyclosporin 100 mg/day; voclosporin 47.4 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 or anifrolumab for 90 days prior to screening;
• • BILAG 2004 index (48) level A disease activity in ≥ 1 organ/system except renal or central nervous system or BILAG 2004 index level B disease activity in ≥ 1 organs/systems if no level A disease activity is present and SLEDAI ≥ 6 (106);
• • Enrollment is approved by adjudication committee within 10 days, which may include retesting and communication with study sites, as necessary.
• • Patients may be considered for enrollment 12 months after rituximab treatment, or 6 months after rituximab treatment if their B cell counts have normalized.
• • Participant Exclusion Criteria
• • Acute SLE flare threatening vital organs;
• • Pregnant or lactating;
• • Moderately serious or serious comorbidities (e.g., diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease, chronic renal insufficiency) that in investigator's opinion confers high risk for adverse events;
• • Patients receiving cyclophosphamide within 3 months;
• • Active chronic infections (e.g., HIV, hepatitis B virus, hepatitis C virus, mycobacteria); patients 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 (which is considered sufficient time to revert GSH to pre-treatment levels (29);
• • Patients who participated in the pilot RCT or are taking daily acetaminophen (≤ 1 g/day prn is allowed if documented);
• • Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus);
• • Patients enrolled in other interventional trials.
• • Patients should not take medications containing acetaminophen (Tylenol) as it may reduce the effectiveness of NAC. 1 g/day of acetaminophen is allowed if documented.
• • Patients should avoid taking more than 500 mg of vitamin C and more than 30 IU of vitamin E daily as both vitamin C and E can confound the study results.