Last updated: November 19, 2023
Sponsor: Yanfeng Hou
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myositis
Lupus
Connective Tissue Diseases
Treatment
N/AClinical Study ID
NCT06149039
YXH2022ZX03223
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The experimental group met the diagnostic criteria of Sontheimer and was diagnosed asCADM with pulmonary interstitial disease.
- Control group 1: The diagnosis was consistent with the diagnostic criteria of Bohanand Perter classification system, and it was confirmed that dermatomyositis wascombined with pulmonary interstitial disease;
- Control group 2: The diagnosis meets the classification criteria of systemic lupuserythematosus revised by the American College of Rheumatology (ACR) in 1997 and isconfirmed as systemic lupus erythematosus combined with pulmonary interstitialdisease, or the diagnosis meets the diagnostic criteria of rheumatoid arthritisintroduced by ACR in 1987 or ACR in 2010 and is confirmed as rheumatoid arthritiscombined with pulmonary interstitial disease.
- Age 18-70 years old;
- Have a good understanding of their own illness and physical condition, haveself-knowledge, can communicate well with others;
- Voluntarily join the study, understand the significance of the experiment and theindicators to be measured, and sign the informed consent.
Exclusion
Exclusion Criteria:
- Severe infection: fever, cough, phlegm, sore throat, abdominal pain, diarrhea,carbuncle and other skin and soft tissue infection and other clinical manifestations,blood routine white blood cell count beyond the normal range (10×109/L);
- Severe cardiovascular disease: including chronic heart dysfunction grade 3 or aboveand various arrhythmias;
- Infectious diseases: hepatitis active stage, AIDS, syphilis, etc.
- Tumor markers of patients suggest the possibility of tumor.
- Patients with neuromuscular disease, inflammatory bowel disease, functionalgastrointestinal disease;
- The patient has other connective tissue diseases or disorders.
Study Design
Total Participants: 120
Study Start date:
April 01, 2023
Estimated Completion Date:
June 30, 2024
Connect with a study center
Yanfeng Hou
Jinan, Shandong 250000
ChinaActive - Recruiting
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