Inflammatory bowel disease
Conditions
Interventions
CD patients:No intervention
UC patients:No intervention
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who visited the Department of Gastroenterology of multiple centers such as the Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine (lead unit) and were diagnosed with Crohn's disease or ulcerative colitis between January 2023 and June 2024. 2. Patients aged = 18 years old should take upadacitinib. 3. Patients who are clinically diagnosed by a doctor as needing to use upadacitinib to treat Crohn's disease or ulcerative colitis.
Exclusion criteria
Exclusion criteria: 1. The subject has any active, chronic or recurrent infections that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study, including hepatitis B or hepatitis C virus, recurrent/disseminated herpes zoster or known history of HIV; 2. The subject has active tuberculosis or meets tuberculosis exclusionary parameters; 3. The subject has a history of malignancy other than a successfully treated nonmelanoma skin cancer or localized carcinoma in situ of the cervix; 4. The subject has prior or current gastrointestinal dysplasia, other than completely removed lowgrade dysplastic lesion in any biopsy performed during or before the screening endoscopy; 5. The subject has a history of spontaneous gastrointestinal perforation (other than appendicitis or mechanical injury), diverticulitis or significantly increased risk of GI perforation per investigator's judgment; 6. The subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same; 7. Screening laboratory and other analyses show any of the following abnormal results: (1) Serum Aspartate Transaminase (AST) or Alanine Transaminase (ALT) > 2 × upper limit of normal (ULN); (2) Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula 160 mmHg or diastolic blood pressure > 100 mmHg; (3) Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism; (4) Known inherited conditions that predispose to hypercoagulability; 9. The subject is considered as disadvantaged groups, including subjects who have psychiatric disorders or cognitive impairment, who are critically ill, or who are pregnant or juveniles.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Medication status;Disease characteristics;Infection Screening; | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic characteristics; | — |
Countries
China
Contacts
Public ContactQian Cao
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed