ulcerative colitis
Conditions
Interventions
Etrasimod treatment group:None
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who voluntarily sign an ethics committee-approved written informed consent form to participate in this study, prior to the initiation of any research procedures; 2. Subjects who are able to understand and comply with the protocol requirements and agree to participate in all study visits; 3. Age 18-75, no gender restriction; 4. Diagnosed with ulcerative colitis for more than 3 months according to the 2023 Chinese Xi'an Guidelines for the Diagnosis and Treatment of Ulcerative Colitis; 5. Modified Mayo score >=6 points, indicating moderate to severe ulcerative colitis patients; 6. Voluntary use of eculizumab.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with Crohn's disease; 2. A history of treatment with any biologic agent or small molecule drug; 3. Undifferentiated Colitis; 4. Cardiac diseases with clinical significance; 5. Pregnancy and lactation; 6. A history of macular edema or opportunistic infections; 7. A history of tumors; 8. The following laboratory test results are abnormal during screening: - AST, ALT > 2 times the upper limit of normal (ULN) - Total bilirubin > 2 times ULN 9. Subjects with bipolar disorder, somatic symptom disorder, personality disorder, schizophrenia, or other psychiatric disorders; 10. Researchers believe that there are any other reasons why the subject is not suitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| endoscopic response;clinical response;endoscopic remission; | — |
Countries
China
Contacts
Public ContactHongjie Zhang
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed