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A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
A Multicenter Open-label Study of the Human Anti-Tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease

Clinical Trial Summary

The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.

Clinical Trial Description

Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (=<21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone etc. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01958827
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 3
Start date September 2013
Completion date October 2015
View Details
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