Remission in Subjects With Crohn's Disease - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00055497

Purpose

Purpose of the study is to test whether subjects who were previously in clinical remission in the M02-403 study can maintain their remission on adalimumab for a period of one year compared to placebo (an inactive substance).

This study was extended post week 52.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Continuation Study of the Human Anti-TNF Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Maintenance of clinical remission [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
Crohn's Disease Activity Index [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
Inflammatory Bowel Disease Questionnaire [ Time Frame: Week 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety Parameters [ Time Frame: Week 56 and in long term extension ] [ Designated as safety issue: Yes ]
Inflammatory bowel disease questionnaire [ Time Frame: Up to week 320 ] [ Designated as safety issue: No ]
Crohn's disease activity index [ Time Frame: Up to week 320 ] [ Designated as safety issue: No ]

Enrollment:	276
Study Start Date:	August 2002
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Biological: placebo Placebo every week
adalimumab EW: Placebo Comparator	Biological: adalimumab During blinded phase and during open label phase: adalimumab 40 mg Every Week Dosing
adalimumab EOW: Placebo Comparator	Biological: adalimumab During blinded phase and during open label phase: Adalimumab 40 mg Every Other Week Dosing

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Subjects must have successfully completed the M02-403 to be eligible for this study
Diagnosis of Crohn's disease
Normal laboratory parameters
Willing and able to give informed consent

Exclusion:

Diagnosis of ulcerative colitis
Women cannot be pregnant or breastfeeding
No previous use of infliximab or other anti-TNF antagonists
No previous history of tuberculosis or listeria infection
No previous history of cancer other than successfully treated skin cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055497

Show 43 Study Locations

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Barry Bittle, Clinical Research Manager )
Study ID Numbers:	M02-433
Study First Received:	March 3, 2003
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00055497 History of Changes
Health Authority:	United States: Food and Drug Administration

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
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

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 September 10, 2009