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Exploring the mechanism of action of gusetuximab in the treatment of Crohn's disease refractory based on a prospective nested case-control study

Exploring the mechanism of action of gusetuximab in the treatment of Crohn's disease refractory based on a prospective nested case-control study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600122959
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Crohn's disease

Interventions

Case (unresponsive) group:None
Control (response ) group:None

Sponsors

Suzhou Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age over 18 years old, gender not limited. 2) Diagnosed with Crohn's disease (according to WHO diagnostic criteria). 3) Patients with moderate to severe active Crohn's disease who have experienced insufficient response, loss of response, or intolerance to traditional or biologic treatments in the past. 4) Capable and willing to provide written informed consent and cooperate with research visits and sample collection.

Exclusion criteria

Exclusion criteria: 1) Relapse is caused by clear infection (such as Clostridium difficile, CMV), use of nonsteroidal anti-inflammatory drugs, or simple obstructive symptoms caused by intestinal stenosis. 2) Plan to use other systemic immunosuppressants or biologics in combination during re induction therapy (allowing for stable doses of aminosalicylic acid preparations). 3) It has been confirmed in the past that there is no response or severe allergic reaction to gusetuximab. 4) Pregnant or lactating women(or planning for pregnancy). 5) There are serious extraintestinal manifestations, active malignant tumors or serious infections (such as herpes virus, hepatitis B, hepatitis, tuberculosis).

Design outcomes

Primary

MeasureTime frame
Intestinal mucosal tissue;

Countries

China

Contacts

Public ContactWen Ke

Suzhou Traditional Chinese Medicine Hospital

wkllcy@163.com+86 137 7612 4976

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026