ulcerative colitis
Conditions
Interventions
the cessation of anti-TNF alpha antibody
Sponsors
Saitama Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients in clinical remission state (partial Mayo scores are 3 points and over ) with anti-TNF alpha antibody without steroid for more than 6 months and over.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse rates after the cessation of anti-TNF alpha antibody (partial Mayo scores(PMS) are 3 and over ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShingo Kato
Saitama Medical Center, Saitama Medical University Department of Gastroenterology and Hepatology
Outcome results
None listed