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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Global Medical Information - Abbott

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Open Label

Outcomes

Primary Outcome Measures

Mean Extent of Exposure - Duration in Days
Extent of exposure for all adalimumab treated subjects
Total Number of Injections of Adalimumab
Extent of exposure for all adalimumab treated subjects
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).

Secondary Outcome Measures

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.
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.
Employment Status: Number of Subjects Employed
Summary of employment status of those employed.
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.
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.
Hematology - Change From Baseline to Final Visit
Changes from the Group mean at baseline are compared to the final visit Group mean value
Clinical Chemistry - Change From Baseline to Final Visit
Changes from the Group mean at Baseline are compared to the final visit Group mean value
Urinalysis - Change From Baseline to Final Visit
Changes from the Group mean at baseline are compared to the final visit Group mean value
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%.
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%.
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%.

Full Information

First Posted
January 26, 2007
Last Updated
November 12, 2009
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00427921
Brief Title
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Acronym
ACCESS
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Open Label
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
160 mg loading dose, 80 mg at week 2, 40 mg every other week
Primary Outcome Measure Information:
Title
Mean Extent of Exposure - Duration in Days
Description
Extent of exposure for all adalimumab treated subjects
Time Frame
Up to 24 weeks
Title
Total Number of Injections of Adalimumab
Description
Extent of exposure for all adalimumab treated subjects
Time Frame
Up to 24 weeks
Title
Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
Description
Treatment compliance (%) = 100 * (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
Description
Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.
Time Frame
Week 12, Week 24, and Last Assessment Value (last nonmissing value)
Title
Overall Health Care Resource Utilization
Description
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.
Time Frame
Up to 24 weeks
Title
Employment Status: Number of Subjects Employed
Description
Summary of employment status of those employed.
Time Frame
Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Title
50% Improvement in Draining Fistula Count and Fistula Healing
Description
Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.
Time Frame
Week 12, Week 24, Last Assessment Value (last nonmissing value)
Title
Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
Description
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.
Time Frame
Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Title
Hematology - Change From Baseline to Final Visit
Description
Changes from the Group mean at baseline are compared to the final visit Group mean value
Time Frame
Up to 24 weeks
Title
Clinical Chemistry - Change From Baseline to Final Visit
Description
Changes from the Group mean at Baseline are compared to the final visit Group mean value
Time Frame
Up to 24 weeks
Title
Urinalysis - Change From Baseline to Final Visit
Description
Changes from the Group mean at baseline are compared to the final visit Group mean value
Time Frame
Up to 24 weeks
Title
Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
Description
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%.
Time Frame
Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)
Title
Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
Description
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%.
Time Frame
Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Title
Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
Description
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%.
Time Frame
Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jimmy Baloukas
Organizational Affiliation
Abbott
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Remo Panaccione, MD, FRCPC
Organizational Affiliation
Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Global Medical Information - Abbott
City
Abbott Park
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.humira.com/
Description
For more information, see attached website

Learn more about this trial

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

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