Status:
COMPLETED
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Lead Sponsor:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Patien...
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 4...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00427921
Start Date
January 1 2007
End Date
January 1 2008
Last Update
November 20 2009
Active Locations (1)
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1
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064