An observational, prospective cohort study to evaluate the long-term safety and efficacy of infliximab SC in patients with Crohn's disease, Ulcerative colitis in Korea
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0009009
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1500
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.
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug survival
- Secondary Outcome Measures
Name Time Method 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