ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Sapporo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age is 16 years or older at the time of obtaining informed consent 2. Partial Mayo (pMayo) score of 3 points or more before IFX / BS1 / BS2 administration 3. After receiving sufficient explanation for participating in this research, the informed consent of the research subject himself / herself has been obtained after sufficient understanding.
Exclusion criteria
Exclusion criteria: 1. Patients for whom a definitive diagnosis of ulcerative colitis has not been obtained 2. Proctitis type patients 3. Patients who have been administered either IFX / BS1 / BS2 in the past (However, cases in which treatment was discontinued after achieving remission by IFX / BS1 / BS2 treatment are excluded only when the same preparation is restarted due to relapse) 4. Patients who have been treated with adalimumab or golimumab in the past and have been primarily ineffective 5. Patients with a history of colectomy 6. Patients with or have a history of malignant disease 7. Patients with serious infectious diseases 8. Others who are judged by the principal investigator to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate 30 weeks after the start of administration in the IFX / BS1 / BS2 groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Remission rate, treatment continuation rate, surgery rate after 2 weeks, 6 weeks, 14 weeks, 22 weeks and 30 weeks 2) Cumulative remission maintenance rate, treatment continuation rate, surgery rate (Kaplanmeier method) 3) Calculation of cross-reactivity of anti-drug antibody against IFX / BS1 / BS2 to other preparations 4) Incidence of adverse events and their contents, presence or absence of abnormal laboratory test values, etc. | — |
Countries
Japan
Contacts
Public ContactTakehiko Katsurada
Hokkaido University Hospital Division of endoscopy
Outcome results
None listed