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Clinical Trials/KCT0009009
KCT0009009
Recruiting
未知

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

Chung-Ang Univerisity Hospital0 sites1,500 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Chung-Ang Univerisity Hospital
Enrollment
1500
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational Study
Sex
All

Investigators

Sponsor
Chung-Ang Univerisity Hospital

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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