A Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn’s Disease (ACCESS)
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn’s Disease
Intervention: Humira (adalimumab) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Jimmy Baloukas, Study Director, Affiliation: Abbott
Summary
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety parameters
Secondary outcome: Change from Baseline in Patient Reported Outcome Measures
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Global Medical Information - Abbott, Abbott Park, Illinois 60064, United States
Additional Information
Starting date: January 2007
Last updated: July 20, 2007
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