None listed
Conditions
Interventions
None listed
Sponsors
Chung-Ang Univerisity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with moderate-severe inflammatory bowel disease (Cron's disease or ulcerative colitis) 2) a patient over the age of 19 3) Any person who intends to administer a subcutaneous injection of Remsima under the authorization of this drug 4) a person who voluntarily agreed in writing to this study 5) It is recommended that women of childbearing age perform appropriate contraception to prevent pregnancy and contraception for at least 6 months after the final administration of the Remsima subcutaneous injection. The implementation of contraception can be determined after discussion with the researcher based on risks and benefits.
Exclusion criteria
Exclusion criteria: 1) A person who is prohibited from being administered as specified in the product description of this drug 2) Pregnant or lactating women 3) Patients who are unfit to participate in the study according to the researcher's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response;Clinical remission;Steroid free remission;Visual Analog Scale (VAS);Primary response rate;Sustainable Clinical response rate;Mucosal healing rate;Fecal calprotectin;Intestinal bacterial (fecal) composition and metabolite analysis;Analysis of metabolites in the blood;Trough level;Adverse event of special interest, AESI | — |
Countries
Korea, Republic of
Contacts
Public ContactChang Hwan Choi
Chung-Ang Univerisity Hospital
Outcome results
None listed