Crohn's disease
Conditions
Interventions
Experimental Group:Ustekinumab combined with thalidomide
Control Group:Ustekinumab combined with placebo
Sponsors
The Second Affiliated Hospital of the Army Medical University PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Adults aged 18-75 years (inclusive), regardless of gender; 2.Meet the diagnostic criteria for Chinese clinical practice guideline on the management of Crohn's disease(2023,Guangzhou); 3.Simplified Crohn’s Disease Activity Index (CDAI) score =8, Best-CDAI score >221, or Simple Endoscopic Score for Crohn’s Disease (SES-CD) >7; 4.Voluntarily agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of cardiac, pulmonary, or renal insufficiency, metabolic syndrome, or other autoimmune diseases; 2.Indications for surgery or history of prior colonic surgery; 3.Women in the preconception planning, pregnancy, or lactation period; 4.Active infectious diseases, such as active tuberculosis; 5.History of cognitive dysfunction; 6.Current or prior participation in other clinical studies within 4 weeks before enrollment; 7.Poor compliance or difficulty completing follow-up; 8.Other reasons deemed by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNF-a;CRP;IL-6;FC;ESR;Thickness of bowel disease;Endoscopic Scoring (SES-CD);Gut microbiota;IL-23; | — |
Secondary
| Measure | Time frame |
|---|---|
| Routine blood markers;Cognition;Liver and kidney function; | — |
Countries
China
Contacts
Public ContactXie Xia
The Second Affiliated Hospital of the Army Medical University PLA
Outcome results
None listed