Crohn’s disease
Conditions
Interventions
UST group (ustekinumab):N/A
IFX group (infliximab optimization):N/A
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female adults,age from 18 to 75 years old. 2. The diagnosis of Crohn's disease was confirmed by the criteria in the Consensus on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018 Beijing). According to CDAI score, the activity of the disease was moderate to severe. 3. Crohn's disease was diagnosed more than 3 months. 4. Patients who used infliximab for the first-line biological agents occurred secondary loss of response for the first time.The drug concentration of IFX is smaller than 3ug/ml. 5. Patients should stop using glucocorticoid for at least 3 weeks. If oral immunosuppressants (including azathioprine and methotrexate) are stable for more than 2 months, they can continue to be used, and other immunosuppressants such as thalidomide and cyclosporine cannot be used. Patients were na?ve to other biologics except infliximab. 6. Stable doses of oral mesalamine during the trial were permitted. Patients should stop using topical mesalamine for at least 2 weeks at baseline.
Exclusion criteria
Exclusion criteria: 1. Patients who were allergic to infliximab or ustekinumab. 2. Diagnosed with ulcerative colitis or indeterminate colitis. 3. The drug concentration of IFX is more than 3ug/ml. 4. There are complications of Crohn's disease, and disease-related surgery may be required during the trial, such as abdominal abscess or perianal abscess, symptomatic intestinal stenosis, fulminant colitis and toxic megacolon. 5. Patients who had undergone intestinal resection, ostomy, or ileoanal pouch surgery, or had short bowel(short bowel syndrome) within 3 months before enrollment. 6. Infections including hepatitis B or C,CMV and active tuberculosis. 7. The patients had clinically serious, progressive or uncontrolled diseases or symptoms(including cardiovascular, neurological, psychiatric, hepatobiliary and renal, hematological, endocrine, etc.). 8. The patients had a malignant tumor or a history of malignancy (including gastrointestinal dysplasia, lymphoproliferative disease, etc.). 9. Pregnant or breastfeeding women,or women who plan to be pregnant. 10. Drugs abuse or alcohol abuse history within 6 months before enrollment. 11. Live vaccination within 3 months before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in IBDQ-32 score at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SF-36 score at week 24;Clinical response rate and clinical remission rate at week 24;Change in IBDQ-32 score, change in SF-36 score, clinical response rate and clinical remission rate at week 8 and week 16;Biological response rate at week 8, week 16 and week 24;Endoscopic remission rate at week 24;Transmural response rate and transmural healing rate at week 24;Cost-effectiveness ratio at week 24;Safety analysis; | — |
Countries
China
Contacts
Public ContactYang Hong, Lu Bo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed