Study on the selection of appropriate patients for the dose escalation of adalimumab in Crohn's disease therapy.

Not Applicable

• Conditions: Crohn' disease

• Registration Number: JPRN-UMIN000024566
• Lead Sponsor: Toho University Medical Center Sakura Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-01
• Study Completion: 2016-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who correspond to the warning or contraindication of the package insert of adalimumab 2.Patients under breast-feeding 3.Patients who do not agree to join the study 4.Patients with previous use of anti-TNF therapy 5.Patients who has neoplasm 6.Patients who had intestinal resection within 6 months 7.Patients with short bowel syndrome 8.When the doctor in charge determines that the patients are not suitable for the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of clinical remission rates at 1 year after randomization between dose escalation group and non-dose escalation group.

Secondary Outcome Measures

Name	Time	Method
Comparison of CDAI/CRP, trough/AAA concentration in blood, and endoscopic remission rate at 24, 48 weeks after randomization. Predictive factors for effectiveness of adalimumab dose escalation.