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A multicenter study of a short-course blood purification sequential reduction IVIG regimen for the treatment of severe autoimmune diseases

A multicenter study of a short-course blood purification sequential reduction IVIG regimen for the treatment of severe autoimmune diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062896
Enrollment
Unknown
Registered
2022-08-23
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe autoimmune disease

Interventions

Blood purification sequentially reduces the amount of IVIG Group:Blood purification
IVIG Group:Immunoglobulin

Sponsors

Dalian Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Complies with the SLE classification standards revised by the American College of Rheumatology (ACR) in 1997 or the SLE classification standards developed by the European League Against Rheumatism (EULAR)/ACR in 2019 and Concomitant lupus nephritis, severe central nervous system damage, severe hemolytic anemia, thrombocytopenic purpura,agranulocytosis, severe heart damage, severe lupus pneumonia, diffuse alveolar hemorrhage, severe lupus hepatitis, and severe vasculitis; 2. The diagnostic criteria for included patients are required to meet the diagnostic criteria for ANCA-associated vasculitis and Eligible patients aged 15 years or older have new or recurrent granulomatous polyangiitis or microscopic polyangiitis, a positive history of myeloperoxidase (MPO) or antiprotease 3 antibodies (PR-3), renal involvement (estimated glomerular filtration rate < 50 ml/min/1.73 m2 body surface area), or lung involvement (diffuse alveolar hemorrhage); 3. Meets diagnostic criteria for catastrophic antiphospholipid antibody syndrome; 4. Diagnosis of dermatomyositis met the criteria of Bohan and Peter with positive anti-MDA-5 antibodies, poor response to immunosuppressants, or interstitial pneumonia; 5. Aged 18-70 years, in compliance with the systemic sclerosis classification criteria established by the 1980 ACR and/or 2013 ACR/EULAR.

Exclusion criteria

Exclusion criteria: 1. This study excluded patients with severe psychiatric disorders, cognitive dysfunction, tumors, severe infectious diseases, and other connective tissue disorders; 2. Other types of vasculitis, including secondary vasculitis, anti-glomerular basement membrane disease, etc.; 3. Anti-MDA5 antibody-positive dermatomyositis: active tuberculosis, active hepatitis B virus infection, cancer; 4. Systemic sclerosis: (1) Pregnancy and lactation; (2) Heart failure, ventricular arrhythmias; (3) Seropositivity of human immunodeficiency virus or hepatitis C virus; (4) Hepatitis B surface antigen positive patients serum hepatitis B virus DNA 10,000 copies/ml or more; (5) The presence of untreated infectious diseases is active; (6) Ultrasonography found thrombosis of liver, hilar and spleen veins; (7) There are serious concomitant diseases (such as severe respiratory or heart diseases), or there is any type of malignancy.

Design outcomes

Primary

MeasureTime frame
Improvement in clinical symptoms;Disease score;

Countries

China

Contacts

Public ContactZhou Hengjie

Dalian Central Hospital

13504250523@163.com+86 13504250453

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026