Optimization of Glucocorticoid Taper Strategies for SLE-ITP
Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Aug 16, 2022
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Complete response was defined as a platelet count ≥100x10\^9/L and the absence of bleeding and new other symptoms.Complete response would be confirmed by platelet counts on 2 separate occasions 7 days apart. Adequate glucocorticoids treatment was defined as at least a dose 50mg/day of prednisone (or equivalent glucocorticoids) for patients with weight less than 50kg, 60mg/day for patients with weight 50-75kg , 75mg/day for patients with weight more than 75kg. Adequate glucocorticoids were used for induction, and the total duration of adequate glucocorticoids treatment for patients enrolled ...
Gender
ALL
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. -
About Fujian Medical University Union Hospital
Fujian Medical University Union Hospital is a leading medical institution in China, dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. As a prominent clinical trial sponsor, the hospital is committed to conducting high-quality studies that contribute to the development of new therapies and medical interventions. With a multidisciplinary team of experienced healthcare professionals and researchers, Fujian Medical University Union Hospital emphasizes ethical standards, patient safety, and scientific rigor in all its clinical trials, fostering collaboration with both local and international research partners to enhance medical knowledge and improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fuzhou, Fujian, China
Patients applied
Trial Officials
He-Jun Li, MD
Principal Investigator
Fujian Medical University Union Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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