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Clinical Trials
Lupus (Systemic Lupus Erythematosus- SLE)
Physician & Study Coordinator
Study Coordinator
Monica Hosler, CRC
email:
Monica.Hosler@sluhn.org
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Synopsis
Phase II Double-blind, placebo-controlled, randomized treatment trial with two arms: one NAC arm with 105 patients and one placebo arm with 105 patients. Healthy subjects receive no drugs and serve as controls for in vitro studies.
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Eligibility Criteria
Inclusion:
- 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 ≤ 100 mg/day; methotrexate ≤ 25 mg/week) 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 (ii) BILAG 2004 index level B disease activity in ≥ 2 organs/systems if no level A disease activity is present and (iii) SLEDAI ≥ 6 (106)
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