Prospective observational study of biologic therapy (Anti-TNF) discontinuation in remitted ulcerative colitis patients and therapeutic optimizatio
Not Applicable
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000011200
- Lead Sponsor
- Saitama Medical Center, Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Patients who cannot continue administration of anti-TNF alpha antibody such as; Patients with severe infection, patients with active tuberculosis, patients with hypersensitivity to anti-TNF alpha antibody, patients with demyelination diseases, such as multiple sclerosis, patients with congestive heart failure, patients with pregnancy, patients with lactation, patients without informed consent, patients who has malignancy and had been cured form malignancy, patients who experienced colectomy, and patients who has been determined not to be suitable to this study by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores(PMS) are 3 and over )
- Secondary Outcome Measures
Name Time Method Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline) Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores are 3 points and over ) in patieints with adalimumab and infliximab Clinical response rate after re-administration of anti-TNF alpha antibody (partial Mayo score less than 3 points, and 30% decrease of the baseline) in patieints with adalimumab and infliximab Biomarkers predicting the relapse after the cessation of anti-TNF alpha antibody