Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT04082416
Eligibility Criteria:
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 disease、organic encephalopathy syndrome、cerebrovascular 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 aminotransferase#ALT#or 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 factor#interleukin 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04082416
Study Brief:
Protocol Section:
NCT04082416