Research & Innovation

Clinical Trials

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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