Difficult-to-treat CD,DTT-CD
Conditions
Interventions
Observation group:None
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Complete the informed consent process in person during the patient's visit and obtain a paper version of the informed consent form with signature and date; 2. Commit to adhering to the study procedures and cooperate with the implementation of the full study process; 3. Aged 18 to 75; 4. According to consensus opinion, based on comprehensive evaluation of clinical presentation, laboratory tests, endoscopy, imaging, pathology, etc., the diagnosis of Crohn's disease (CD) is confirmed; 5. According to IOIBD consensus, meet the criteria for DTT-CD (satisfy at least one of the following four conditions): (1) The patient has experienced treatment failure with at least two biologics or advanced small molecule drugs with different mechanisms; (2) CD recurrence after two or more intestinal resections; (3) Complex perianal lesions; (4) The patient is unable to undergo appropriate clinical management due to psychological factors; 6. Pre-treatment colonoscopy shows active lesions or clinical presentation is assessed as clinical activity. Active lesions are defined as a Simple Endoscopic Score for Crohn’s Disease (SES-CD) >2, and clinical activity is defined as CDAI >= 150; 7. Complete standard UPA induction therapy (45 mg, once daily, for 12 weeks), achieve clinical response in efficacy assessment, and plan to continue UPA maintenance therapy thereafter.
Exclusion criteria
Exclusion criteria: 1.Decline to participate in the study or are unable to comply with follow-up investigations; 2.Participation in other clinical trials during the study period; 3.Denied a diagnosis of Crohn's disease during follow-up; 4.Severe impairment of cardiac, hepatic, or renal function; 5.Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate;Endoscopic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corticosteroid-free clinical remission rate;Clinical remission rate;Clinical response rate;Clinical response rate;Adverse event;Endoscopic remission rate; | — |
Countries
China
Contacts
Public ContactYubei Gu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed