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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: adalimumab (Biological); adalimumab (Biological); placebo (Biological)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Morio Ozawa, Study Director, Affiliation: Abbott Japan Co.,Ltd


The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Clinical Details

Official title: A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4

Secondary outcome:

Clinical Remission (CDAI < 150) at Week 2

Clinical Response (CR-70 and CR-100) in Period A

Clinical Response (CR-70 and CR-100) in Period B

Clinical Remission (CDAI <150) at Week 6 and Week 8


Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Crohn's Disease Activity Index (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

tuberculosis (TB), or Human immunodeficiency virus (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

Locations and Contacts

Aichi, Japan

Chiba, Japan

Ehime, Japan

Fukuoka, Japan

Hiroshima, Japan

Hokkaido, Japan

Hyogo, Japan

Kagawa, Japan

Kanagawa, Japan

Kochi, Japan

Kyoto, Japan

Miyagi, Japan

Okayama, Japan

Okinawa, Japan

Osaka, Japan

Shiga, Japan

Shizuoka, Japan

Tokyo, Japan

Additional Information

Starting date: February 2007
Last updated: June 20, 2011

Page last updated: August 23, 2015

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