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Real-World Effectiveness and Safety of Upadacitinib in Difficult-to-Treat Crohn’s Disease: A Multicenter Study from China

Real-World Effectiveness and Safety of Upadacitinib in Difficult-to-Treat Crohn’s Disease: A Multicenter Study from China

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108912
Enrollment
Unknown
Registered
2025-09-09
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult-to-treat CD,DTT-CD

Interventions

Observation Group:None

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Clinical remission rate;

Secondary

MeasureTime frame
Clinical response rate;Adverse event;

Countries

China

Contacts

Public ContactYubei Gu

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

gyb11809@rjh.com.cn+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026