Difficult-to-treat CD,DTT-CD
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 ~ 75 years old; 2. According to consensus opinion, based on comprehensive clinical manifestations, laboratory tests, endoscopy, imaging, pathology, etc., the diagnosis is confirmed as CD; 3. According to IOIBD consensus opinion, meets DTT-CD criteria (one of the following four items must be satisfied): (1) The patient has failed treatment with at least two biologics and advanced small molecules with different mechanisms; (2) Recurrence of CD after two or more intestinal resections; (3) Complicated perianal disease; (4) The patient is unable to receive appropriate clinical management due to psychological factors; 4. Pre-treatment colonoscopy shows active lesions or clinical evaluation is at the active stage. Active lesions are defined as a Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 2, and the active clinical stage is defined as CDAI >= 150; 5. Receives standard UPA induction treatment. Standard treatment is defined as 45mg once daily.
Exclusion criteria
Exclusion criteria: 1.Severe impairment of cardiac, hepatic, or renal function; 2.Pregnant or breastfeeding women; 3.Missing more than 30% of case data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate;Adverse event; | — |
Countries
China
Contacts
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine