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

Crohn's Disease Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427921
• Other study ID #: W06-405
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2007
• Last updated: November 12, 2009
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: November 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• adalimumab
160 mg loading dose, 80 mg at week 2, 40 mg every other week

Locations

Country	Name	City	State
United States	Global Medical Information - Abbott	Abbott Park	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Extent of Exposure - Duration in Days		Up to 24 weeks	Yes
Primary	Total Number of Injections of Adalimumab		Up to 24 weeks	No
Primary	Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.		Up to 24 weeks	No
Secondary	Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).		Week 12, Week 24, and Last Assessment Value (last nonmissing value)	No
Secondary	Overall Health Care Resource Utilization		Up to 24 weeks	No
Secondary	Employment Status: Number of Subjects Employed		Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)	No
Secondary	50% Improvement in Draining Fistula Count and Fistula Healing		Week 12, Week 24, Last Assessment Value (last nonmissing value)	No
Secondary	Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment		Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)	No
Secondary	Hematology - Change From Baseline to Final Visit		Up to 24 weeks	Yes
Secondary	Clinical Chemistry - Change From Baseline to Final Visit		Up to 24 weeks	Yes
Secondary	Urinalysis - Change From Baseline to Final Visit		Up to 24 weeks	Yes
Secondary	Work Productivity and Activity Impairment - Change From Baseline in Absenteeism		Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)	No
Secondary	Work Productivity and Activity Impairment - Change From Baseline in Presenteeism		Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)	No
Secondary	Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment		Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)	No

External Links

•   For more information, see attached website