Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS) - Full Text View

Purpose

To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

Condition	Intervention	Phase
Crohn's Disease	Biological: adalimumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Mean Extent of Exposure - Duration in Days [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Total Number of Injections of Adalimumab [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections. [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline). [ Time Frame: Week 12, Week 24, and Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]
Overall Health Care Resource Utilization [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
Employment Status: Number of Subjects Employed [ Time Frame: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]
50% Improvement in Draining Fistula Count and Fistula Healing [ Time Frame: Week 12, Week 24, Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment [ Time Frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]
Hematology - Change From Baseline to Final Visit [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Clinical Chemistry - Change From Baseline to Final Visit [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Urinalysis - Change From Baseline to Final Visit [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism [ Time Frame: Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value) ] [ Designated as safety issue: No ]
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism [ Time Frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment [ Time Frame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value) ] [ Designated as safety issue: No ]

Enrollment:	304
Study Start Date:	January 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Open Label	Biological: adalimumab 160 mg loading dose, 80 mg at week 2, 40 mg every other week Other Names: ABT-D2E7 adalimumab Humira

Detailed Description:

This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.

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; Crohn's Disease Activity Index score > 220 OR Harvey Bradshaw Index 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
Study Chair:	Remo Panaccione, MD, FRCPC	Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada

More Information

Additional Information:

For more information, see attached website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Tom Koutsavlis, Medical Director, Abbott
ClinicalTrials.gov Identifier:	NCT00427921 History of Changes
Other Study ID Numbers:	W06-405
Study First Received:	January 26, 2007
Results First Received:	January 9, 2009
Last Updated:	November 12, 2009
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal

Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013