Occurrence of Anti-drug antibody and change of drug level for 1 year after CT-P13 therapy and their Impact on clinical outcomes in moderate to Severe inflammatory bowel disease
Not Applicable
Recruiting
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002222
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1) Moderate to severe active Inflammatory Bowel Disease
[Moderate to severe criteria]
-Crohn's disease: CDAI score = 220, Ulcerative colitis: Mayo score = 6
2) Over 19 years of age
3) Anti-TNF naive
4) Patients who voluntarily signed a consent form
Exclusion Criteria
1) A foreigner
2) A history of hypersensitivity to humanized proteins
3) Tuberculosis infection
4) Chronic hepatitis B not being treated
5) HIV infection or positive
6) NYHA class III/IV heart disease
7) Infection, Malignant tumor, Previous history of dysplasia of the colon or small intestine within the previous 5 years
8) Pregnant women, lactating women
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of trough drug concentration(TDC), Incidence of ADA
- Secondary Outcome Measures
Name Time Method Clinical remission through 54 weeks associated with TDC and ADA;Concomitant medication impact on TCD and ADA;Mucosal healing(UC) with TDC and ADA;Fecal calprotectin, FIT and clinical remission