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

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00445939

Purpose

To demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.

Condition	Intervention	Phase
Crohn's Disease	Biological: adalimumab Biological: placebo	Phase II Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Abbott:

Primary Outcome Measures:

The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Remission (CDAI < 150) at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Clinical Response (CR-70 and CR-100) in Period A [ Time Frame: Weeks 2 and Week 4 ] [ Designated as safety issue: No ]
Clinical Response (CR-70 and CR-100) in Period B [ Time Frame: Week 6 and Week 8 ] [ Designated as safety issue: No ]
Clinical Remission (CDAI <150) at Week 6 and Week 8 [ Time Frame: Week 6 and Week 8 ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	February 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab 160 mg/80 mg: Experimental	Biological: adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg: Experimental	Biological: adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo: Placebo Comparator	Biological: placebo Placebo at Week 0 and Week 2

Eligibility

Criteria

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, or 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445939

Locations

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators

Study Director:

Morio Ozawa

Abbott Japan Co.,Ltd

More Information

No publications provided

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M04-729
Study First Received:	March 7, 2007
Results First Received:	December 23, 2008
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00445939 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Anti-Inflammatory Agents
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases

Adalimumab
Ileal Diseases
Digestive System Diseases
Crohn Disease
Gastroenteritis
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009