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Sponsored by: |
Abbott |
Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00524537 |
The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.
Condition | Intervention |
Crohn's Disease |
Drug: adalimumab |
Genetics Home Reference related topics: | Crohn disease |
MedlinePlus related topics: | Crohn's Disease |
ChemIDplus related topics: | Adalimumab |
Study Type: | Observational |
Study Design: | Other, Prospective |
Official Title: | A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD) |
Estimated Enrollment: | 5000 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
Open Label |
Drug: adalimumab
Physicians prescribe adalimumab as per the current label
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
As per the current approved Label
Inclusion Criteria:
Exclusion Criteria:
Contact: Lawrence P McNamee | 1-973-394-5656 | lawrence.mcnamee@abbott.com |
Contact: Daniel D Byczkowski, MS | 973-394-5512 | daniel.byczkowski@abbott.com |
Show 275 Study Locations |
Abbott |
Study Director: | Beverly Paperiello | Abbott |
Responsible Party: | Abbott Laboratories ( Lawrence McNamee ) |
Study ID Numbers: | P06-134 |
First Received: | August 31, 2007 |
Last Updated: | August 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00524537 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency |
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