A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects with Crohn's Disease

Phase 2

• Conditions: Crohn's disease

• Registration Number: JPRN-jRCT2080220357
• Lead Sponsor: Abbott Japan Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- CDAI score of >=220 and =<450
- If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
Exclusion criteria:
- Ulcerative colitis or indeterminate colitis
- History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Body weight is below 30 kg
- Surgical bowel resections within the past 6 months
- Females who are pregnant or breast-feeding or considering becoming pregnant during the study

Exclusion Criteria

Exclusion Criteria:
- Subject with a current diagnosis of ulcerative colitis or indeterminate colitis as determined by the investigator
- Subject has a history of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Subject's body weight is below 30 kg
- Subject who has had surgical bowel resections within the past 6 months
- Pregnant women

Study & Design

• Study Type: Interventional
• Study Design: Not specified