Autoimmune diseases (ankylosing spondylitis, systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes, erythroderma)
Conditions
Sponsors
Boao Evergrande International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ankylosing spondylitis: (1) Aged 18-65 years, gender is not limited; (2) All patients with ankylosing spondylitis met the AS New York criteria revised in 1984. AS was diagnosed at screening and baseline, and 2 of the following conditions were met: BASDAI score >= 4 points; total back pain >= 4 points as assessed on the visual analog scale (VAS) for pain; (3) Morning stiffness time >= 1 hour; (3) All patients with ankylosing spondylitis were positive for HLA-B27; (4) All patients with ankylosing spondylitis were ineffective or could not tolerate standard treatment of more than one NSAIDs or more than one DMARDs; (5) The patient needs to sign the informed consent; 2. Systemic lupus erythematosus: (1) Aged 18-65 years, gender is not limited; (2) All patients with systemic lupus erythematosus, according to the systemic lupus erythematosus International Collaborative Group SLICC2012 criteria, meet 4 criteria, including at least 1 clinical criteria and 1 immunological criteria; or renal biopsy confirmed lupus nephritis, and at the same time Antinuclear antibody positive or anti-ds-DNA antibody positive; (3) Among all patients with systemic lupus erythematosus, the patients with SLEDAI score <=14 points; (4) The patient needs to sign the informed consent; 3. Rheumatoid Arthritis: (1) Aged 18-65 years, gender is not limited; (2) All patients with rheumatoid arthritis met the new ACR/EULAR criteria (American College of Rheumatology/European Federation for the Prevention and Treatment of Rheumatism, 2010); (3) In the early stage of rheumatoid arthritis, the symptoms are obvious (morning stiffness/pain or tenderness) or related test indicators are positive, there is functional damage or slight functional damage, and there is no organic or irreversible damage; (4) The patient needs to sign the informed consent; 4. Type I diabetes: (1) Aged <= 40 years, gender is not limited; (2) The first diagnosis is type 1 diabetes mellitus (without acute complications - ketoacidosis, hypoglycemic coma, hyperosmolar coma, lactic acidosis, etc.) (ICD-10: E10.901); (3) In line with "Pediatrics" (Shen Kunling et al. editor-in-chief, People's Health Publishing House, 2016, 1st edition), "Zhu Futang Practical Pediatrics (8th Edition)" (People's Health Publishing House, 2015), "2018" ISPAD Clinical Practice Consensus Guidelines: Definition, Epidemiology and Classification of Diabetes in Children and Adolescents" Diagnostic Criteria; (4) Classification: immune-mediated (type IA); (5) The patient needs to sign the informed consent; 5. Erythroderma: (1) Aged 18-65 years, gender is not limited; (2) Comply with the diagnostic criteria of "Clinical Diagnosis and Treatment Guidelines - Dermatology and Venereal Diseases", "Clinical Technical Operation Standard - Dermatology and Venereal Diseases", and "Chinese Clinical Dermatology" 4th Edition Erythroderma; (3) Take erythroderma as the first diagnosis; (4) The main medical records required are complete; (5) Patients need to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Ankylosing spondylitis: (1) Complete fusion of spinal joints; (2) Those who are allergic to any drug ingredient (protein ingredient); (3) Patients with joint or spine surgery experience within 4 weeks before receiving treatment; (4) Patients who have experienced the application of biological agents within 24 weeks before treatment; (5) Patients who have used other drugs such as thalidomide within 24 weeks before treatment; (6) Lactating women; (7) AIDS (acquired immune deficiency syndrome, AIDS) patients, human immunodeficiency virus (human immunodeficiency virus, HIV) antibody, syphilis helix antibody, hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBV-Ag) any one positive; (8) have a history of tumor; (9) a history of active tuberculosis or tuberculosis, and chest imaging in the screening period has past tuberculosis lesions, tuberculin (purified protein derivative, PPD), gamma interferon-releasing tuberculosis infection T cell spot test (TSPOT) )positive; (10) Other autoimmune diseases other than AS, such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), etc.; (11) Acute and chronic inflammation of the urinary system or respiratory tract; (12) Have a history of serious chronic diseases of vital organs; (13) There is drug or alcohol abuse, and there are medical, psychological or social conditions that may interfere with the patients participation in research or affect the evaluation of research results; (14) Persons with mental disorders; (15) Those who have participated in or are participating in clinical trials of other drugs or medical devices within 90 days before screening; (16) Those who cannot accept the collection of blood or body fluids and other specimens, clinical examination or imaging examination for various reasons; (17) Those who have other factors that are not suitable for participating in this study as assessed by the investigator; 2. Systemic lupus erythematosus: (1) Patients with severe lupus nephritis at screening (24-hour protein quantification > 6g, or serum creatinine > 2.5mg/dL or 221µmol/L), or active renal disease requiring emergency treatment, or requiring hemodialysis, or Patients treated with high-dose glucocorticoids (prednisone or its equivalent, dose > 100 mg/day); (2) Suffering from active central nervous system (CNS) lupus erythematosus (including epilepsy, mental disorders, organic brain lesions, cerebrovascular accident (CVA), or central nervous system vasculitis) at the time of screening and requiring intervention therapy By; (3) Severe lupus lung damage (including pulmonary hypertension, pulmonary hemorrhage, pulmonary infarction, pulmonary atrophy, pulmonary fibrosis, etc.) at the time of screening; (4) Severe lupus heart damage (including coronary vascular involvement, Libman-Sacks endocarditis, myocarditis, cardiac tamponade and malignant hypertension, etc.) at the time of screening; (5) Patients with previous or existing acute and chronic diseases unrelated to SLE, with significantly unstable or uncontrollable clinical symptoms (such as: cardiovascular and cerebrovascular diseases, lung diseases, blood diseases, gastrointestinal diseases, liver diseases, kidney diseases, neurological disease, malignancy, or infectious disease), which the investigator believes may confound trial results or present unpredictable risks to patients; (6) Infection: The subject has acute or chronic infection requiring treatment (such as tuberculosis, Pneumocyst
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Efficacy evaluation index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological index; | — |
Countries
China
Contacts
Public ContactZhou Zhonghua
Boao Evergrande International Hospital
Outcome results
None listed