A Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

This study has been completed.

First Received: January 26, 2007 Last Updated: July 22, 2008 History of Changes

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00427921

Purpose

To make adalimumab available to subjects suffering from moderately to severely active CD and to expand the safety information on adalimumab. The study will also assess changes in Patient Reported Outcome Measures from baseline.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Immunoglobulins Adalimumab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Safety parameters [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from Baseline in Patient Reported Outcome Measures [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Enrollment:	350
Study Start Date:	January 2007
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open Label	Biological: adalimumab 160 mg loading dose, 80 mg at week 2, 40 mg every other week

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females 18 years of age and older
Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; CDAI score > 220 OR HBI equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")

Exclusion Criteria:

History of cancer other than some skin and cervical cancers
History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
Subjects with other, poorly controlled medical conditions
Subjects with any prior exposure to Tysabri® (natalizumab)
Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
Female subjects 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: NCT00427921

Locations

United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Jimmy Baloukas

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Tom Koutsavlis, Medical Director )
Study ID Numbers:	W06-405
Study First Received:	January 26, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00427921 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

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

Ileal Diseases
Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Crohn Disease
Antirheumatic Agents
Gastroenteritis
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Ileitis
Gastrointestinal Diseases
Enteritis
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab

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

ClinicalTrials.gov processed this record on September 10, 2009