Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Department of Medicine, Shiga University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with moderate to severe UC despite concurrent treatment (Mayo score more than 3 points or Mayo sub-score more than 2 points CAI more than 5 points).
Exclusion criteria
Exclusion criteria: (1) Patients < 15 years of age (2) Pregnant or likely to be pregnant women (3) Patients with malignancy (4) Patients with severe infection (5) Patients who treated or dose escalated with steroid within 2 weeks. (6) Patients who treated with IFX within 8 weeks (7) Patients who treated or dose escalated with Azathioprine and 6-mercaptopurine within 8 weeks. (8) Patients who treated or dose escalated with tacrolimus within 4 weeks (9) Patients who treated with ciclosporin within 2 weeks (10) Patients who treated with cyteapheresis within 2 weeks (11) Patients not approving the study consent (12) Patients judged as inadequate at the discretion of physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate and mucosal healing rate at week 8 and 52, based on status of ADA serum concentration and AAA | — |
Secondary
| Measure | Time frame |
|---|---|
| CAI and Mayo score at each evaluation time, based on status of ADA serum concentration and AAA. ADA serum concentration and AAA at each evaluation time based on status of IFX experience and concomitant use of immunomodulators. The predictors of remission rate and mucosal healing rate at week 8 and 52. Adverse event based on status of AAA. etc | — |
Countries
Japan
Contacts
Public ContactHirotsugu Imaeda
Shiga University of Medical Science Department of Medicine
Outcome results
None listed