Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study)

Short-Term Outcomes of Adalimumab for Patients with Crohn's Disease and Associated Prognostic Factors: a Multicenter Retrospective Cohort Study in Japan (SAPPORO study) - Evaluation of Adalimumab in Crohn's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018483

Enrollment

200

Registered

2015-11-01

Start date

2015-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Crohn's disease who received adalimumab induction therapy from October 2010 to March 2015.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Complete remission rate at 4 weeks following adalimumab administration.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactHiroki Tanaka

Sapporo Kosei General Hospital IBD Center

hirokit@mtc.biglobe.ne.jp011-261-5331

Outcome results