oss of response to infliximab in patients with intractable ulcerative colitis: Clinical features and outcomes.
Not Applicable
Completed
- Conditions
- ulcerative colitis
- Registration Number
- JPRN-UMIN000016640
- Lead Sponsor
- Hyogo College of Medicine, Department of Inflammatory Bowel Disease, Division of Internal Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.