Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study)
Not Applicable
- Conditions
- Crohn's disease
- Registration Number
- JPRN-UMIN000018483
- Lead Sponsor
- IBD Center, Sapporo Kosei General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1) The patient whom HBI before adalimumab administration was not able to measure. 2) The patients with HBI of <5 before adalimumab administration. 3) The patient that injection method within 4 weeks from adalimumab administraton is different from an package insert. 4) The patient with history of adalimumab treatment. 5) The patient with history of anti-TNF antibody agtents except infliximab. 6) The patient having a stoma 7) The patient who was administered adalimumab to prevent a postoperative recurrence.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission rate at 4 weeks following adalimumab administration.
- Secondary Outcome Measures
Name Time Method Complete remission rates at 2, 8 and 12 weeks following adalimumab administration. Remission rates at 2, 4, 8 and 12 weeks following adalimumab administration. Change of HBI, CRP and alubumin value at 2, 4, 8 and 12 weeks following adalimumab administration. Predictors for remission and complete remission rates at 2, 4, 8 and 12 weeks following adalimumab administration. Bowel resection rate at 12 week following adalimumab administration. Predictors for bowel resection rate at 12 week fllowing adalimumab administration. Reasens of adalimumab discontinuation. Adverse event. etc.