Inflammatory bowel disease: ulcerative colitis, Crohn's disease
Conditions
Interventions
Daytime dosing group:upadacitinib administered during the daytime
Nighttime dosing group:upadacitinib administered during the nighttime
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years, both sexes; 2. Patients definitively diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) for at least 3 months according to the diagnostic criteria set forth in the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an) and the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou); 3. Disease activity is moderate-to-severe: UC patients are assessed by the modified Mayo score, and CD patients by the simplified Crohn's Disease Activity Index; 4. Patients are scheduled to receive upadacitinib (UPA) therapy: UC patients receive induction therapy with 45 mg qd (once daily) for 8 weeks, followed by maintenance therapy with 15 mg qd; CD patients receive induction therapy with 45 mg qd for 12 weeks, followed by maintenance therapy with 15 mg qd; 5. Complete clinical data are available; 6. Adequate conditions for follow-up: long-term feedback via a mobile application; 7. Any chronotype (morning-type, evening-type, or intermediate-type) is acceptable.
Exclusion criteria
Exclusion criteria: 1. General conditions: History of psychiatric disorders or cognitive impairment; History of significant chronic diseases, such as malignant tumors, active infections, severe respiratory or cardiovascular diseases, or acute/chronic kidney diseases; Known intestinal diseases such as celiac disease, or uncontrolled major chronic diseases such as cerebral infarction, cancer, heart failure, etc.; Impaired liver function or autoimmune diseases such as systemic lupus erythematosus; Use of antibiotics, probiotics, prebiotics, or proton pump inhibitors within the past 1 month; Female patients who are pregnant, lactating, or planning to become pregnant; Patients or their family members who are unable to understand the conditions and objectives of this study, or who do not consent to follow-up. 2. Concomitant medications and treatments: Patients receiving corticosteroid therapy; Patients receiving immunosuppressive therapy with MTX/AZA, etc.; Patients receiving other biologic agents or small-molecule drugs. 3. Medications and treatments during the screening period: Patients who have received Chinese herbal medicine injections, intravenous corticosteroids, live vaccines, cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, thalidomide, or fecal microbiota transplantation within 30 days prior to screening; Patients requiring or receiving any parenteral nutrition and/or total enteral nutrition; Systemic use of known strong cytochrome P450 3A (CYP3A) inhibitors or strong CYP3A inducers from screening to the end of the study. Examples of commonly used strong CYP3A inhibitors include grapefruit juice, voriconazole, boceprevir, cobicistat, clarithromycin, and conivaptan; examples of strong CYP3A inducers include avasimibe, carbamazepine, phenytoin, rifampin, St. John's Wort, and phenobarbital. 4. Prior medications and treatments: Patients who have received any of the following: Any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening, or who are currently participating in another interventional study; Exposure to JAK inhibitors within 30 days prior to screening; Intravenous corticosteroids within 14 days prior to screening or during the screening period; Therapeutic enemas or suppositories (i.e., rectal aminosalicylates/corticosteroids) within 14 days prior to the screening endoscopy or during the screening period, except as required for the endoscopy itself; Plasmapheresis within 60 days prior to screening or during the screening period; Cannabis use (whether recreational or medical) within 14 days prior to screening, or any clinically significant history of drug or alcohol abuse within the past 6 months; Non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days prior to baseline (except for topical NSAIDs and low-dose aspirin used for cardiovascular protection); Prior stem cell transplantation. 5. Disease-related conditions: Patients with any of the following known complications: Abscess (abdominal or perianal); Symptomatic intestinal strictures; Complete loss of 2 out of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; Fulminant colitis; Toxic megacolon; Or any other clinical manifestation that may require surgery during the study period. Patients with an ostomy or ileal pouch-anal anastomosis; Patients diagnosed with conditions that may interfere with drug absorption, including but not limited to short bowel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nighttime symptom;Inflammatory markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep architecture and stability; | — |
Countries
China
Contacts
Public ContactHong Yang
Peking Union Medical College Hospital
Outcome results
None listed