Status:
RECRUITING
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
Cedars-Sinai Medical Center
University of Rochester
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack ...
Detailed Description
Subjects will take NAC in a dose range of 2.4 g/day to 4.8 g/day which will be titrated to tolerance during an initial 3-month open label period. After the 3-month open label period, patients in each ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT00775476
Start Date
May 5 2022
End Date
September 30 2028
Last Update
November 29 2024
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06519
3
Hospital for Special Surgery
New York, New York, United States, 10021
4
SUNY Upstate Medical University
Syracuse, New York, United States, 13210