ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who had been diagnosed with ulcerative colitis according to the diagnostic criteria defined by the research group of inflammatory bowel disease in the Ministry of Health, Labor and Welfare in Japan. 2) Ulcerative colitis patients who had been receiving scheduled IFX treatment for over 6 months. 3) Ulcerative colitis patients who had been assessed clinical/mucosal disease activity by experienced clinician before initial IFX administration. 4) Patients who were able to provide written informed consent before being included this study.
Exclusion criteria
Exclusion criteria: 1) Patients who had not showed initial response to IFX before. 2) Patients who had been treated with IFX at short intervals (within 8 weeks) in their exacerbating period. 3) Patients who could not provide written informed consent before being included this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of intractable UC patients who lost response to IFX maintenance therapy. Loss of response to IFX was defined as: patients who lost response to IFX during over 6 month maintenance therapy with scheduled every 8 weeks IFX following the initial response to IFX. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of serum IFX concentration and the ATI status in the included UC patients. Comparison of endoscopic/ histological findings between patients who lost response to IFX maintenance therapy and patients who continued to respond. | — |
Countries
Japan
Contacts
Public ContactTakako Miyazaki MD. PhD.
Hyogo College of Medicine Department of Inflammatory Bowel Disease, Division of Internal Medicine
Outcome results
None listed