Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Completed · Phase 3
Conditions studied: Crohn's Disease
In brief
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.
Key facts
- Study ID
- NCT00427921
- Run by
- Abbott
- People needed
- 304
- Starts
- 2007-01-01
- Expected to finish
- 2008-01-01
- Last updated by the study team
- 2009-11-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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")
You may not qualify if…
- 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
Where it is running
- Global Medical Information - Abbott — Abbott Park, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.