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:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05506033
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged 14-75 (including 14 and 75);
2. It meets the 2012 Systemic lupus Erythematosus International Collaborative Group (SLICC) classification criteria or the 2019 ACR and European Society of Rheumatology (EULAR) classification criteria ;
3. severe SLE-ITP patients with PLT≤30x10\^9/L at onset and complete response (PLT ≥100x10\^9/L) after induction therapy within 3 weeks;
4. Prior to the commencement of any study-specific procedure, the patient or legal representative must provide signed and dated written informed consent.
Exclusion Criteria:
1. Relapse in the presence of glucocorticoid and/or immunosuppressive maintenance therapy;
2. Combined with antiphospholipid syndrome;
3. Combined with other important organ damage such as lupus nephritis, neuropsychiatric lupus;
4. Coexisting immune diseases require glucocorticoid and/or immunosuppressive therapy;
5. There are serious comorbidities affecting treatment such as diabetes, severe hypertension, coronary heart disease;
6. self-evaluation affected by poor understanding ability, vision decline and other reasons ;
7. Poor adherence and failure to adhere to treatment as prescribed. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
75 Years
Study:
NCT05506033
Study Brief:
Protocol Section:
NCT05506033