Last updated on December 2019

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 65 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Active SLE disease#and at least according with 4 of the 11 items of the American College of Rheumatology (ACR) criteria 1997.
  • Age & Gender: Male or female between 18 and 65 years of age inclusive#and the sex ratio is not limited
  • Signed informed consent form#willing or able to participate in all required study evaluations and procedures.
  • SELENA-SLEDAI(Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index) score 8 during the screening period.and if there is Hypo-complement or the Anti-dsDNA score, SELENA-SLEDAI disease activity score should be at least 6 at screening .
  • Autoantibody-positive
  • on a stable SLE treatment regimen for at least 30 days prior to Day 1, which consisted of any of the following (alone or in combination): cortical hormone,anti-malarials,non-steroidal anti inflammatory drugs (NSAIDs),or any immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate

Exclusion Criteria:

  • kidney disease Severe lupus nephritis 8 weeks prior to randomization (designed as:Urine protein>6g/24h or serum creatinine ( SCr>2.5mg/dL or 221umol/L ) or needing for hemodialysis or receipting high dose cortical hormone 14 days( metacortandracin>100mg/d or equivalent)
  • Central nervous system disease caused by SLE or non SLE 8 weeks prior to randomization (including epilepsy mental diseaseorganic encephalopathy syndromecerebrovascular accident, encephalitis, central nervous system vasculitis;
  • there are serious heart, liver, kidney and other important organs and blood, endocrine system diseases and medical history;

Evaluation criteria for severity :

  1. Alanine aminotransferaseALTor aspartate aminotransferase (AST) 2 upper limit of normal (ULN);
  2. Creatinine Clearance (Ccr)<30ml/min;
  3. White Blood Cell Count(WBCs)<2.5x 10(9)/L;
  4. hemoglobin<85g/L;
  5. Platelets<50x 10(9)/L.
    • Have a historically active hepatitis or active hepatitis or medical history,hepatitis B :Patients with positive HBsAg are excluded.;Hepatitis C: Patients with hepatitis C antibody positive are excluded;
    • Immune deficiency, uncontrolled severe infection and patients with active or recurrent peptic ulcer;
    • Pregnant , lactating women and men or women who have birth plans in the past 12 months ;
    • Have a history of allergic reaction to human biological medicines.
    • Receipt of live vaccine within 1 month;
    • Have participated in any clinical trial in the first 28 days of the initial screening or 5 times half-life period of the study compound (taking the time for the elderly).
    • Have received treatment with B cell targeted therapy such as Rituximab or Epratuzumab etc.
    • Receipt of anti-tumor necrosis factorinterleukin receptor antagonist
    • Receipt of IV immunoglobulin(IVIG),prednisone>100mg/d more than 14 days or plasma exchange;
    • There are active infections (such as herpes zoster, human immunodeficiency virus (HIV) virus infection, active tuberculosis, etc.) during the screening period;
    • Patients have depression or the significant suicide ideation;
    • Interleukin(IL)-2, thalidomide, Tripterygium wilfordii and traditional Chinese medicine preparation containing Tripterygium Wilfordii were used within 28 days before randomization
    • Investigator considers candidates not appropriating for the study.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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