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

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)

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Biological: adalimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 304
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Open Label	Biological: adalimumab; 160 mg loading dose, 80 mg at week 2, 40 mg every other week; Other Names: ABT-D2E7; Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Extent of Exposure - Duration in Days	Extent of exposure for all adalimumab treated subjects	Up to 24 weeks
Total Number of Injections of Adalimumab	Extent of exposure for all adalimumab treated subjects	Up to 24 weeks
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.	Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).	Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.	Week 12, Week 24, and Last Assessment Value (last nonmissing value)
Overall Health Care Resource Utilization	From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization.	Up to 24 weeks
Employment Status: Number of Subjects Employed	Summary of employment status of those employed.	Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
50% Improvement in Draining Fistula Count and Fistula Healing	Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.	Week 12, Week 24, Last Assessment Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment	Scores are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity (0% = no impairment; 100% = total loss of work productivity). Minimal clinically important difference = 7 points. Measure is Mean percent change.	Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Hematology - Change From Baseline to Final Visit	Changes from the Group mean at baseline are compared to the final visit Group mean value	Up to 24 weeks
Clinical Chemistry - Change From Baseline to Final Visit	Changes from the Group mean at Baseline are compared to the final visit Group mean value	Up to 24 weeks
Urinalysis - Change From Baseline to Final Visit	Changes from the Group mean at baseline are compared to the final visit Group mean value	Up to 24 weeks
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism	The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.	Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism	The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.	Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment	The Work Productivity and Activity Impairment (WPAI) questionnaire is a validated, self-administered tool used to assess the impact of disease on productivity. There are four component scores for WPAI: absenteeism, presenteeism, total work productivity impairment, daily activity impairment. The score for each component ranges from 0% to 100% (0%=no impairment; 100%=total loss of work productivity or activity). The minimal clinically important difference (MCID) is an absolute change of 7%.	Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• For more information, see attached website

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 26, 2007
• First Submitted That Met QC Criteria: January 26, 2007
• First Posted (Estimate): January 29, 2007

Study Record Updates

• Last Update Posted (Estimate): November 20, 2009
• Last Update Submitted That Met QC Criteria: November 12, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: W06-405