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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00524537 |
Purpose
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 |
Biological: adalimumab |
| Study Type: | Observational |
| Study Design: | Cohort, 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: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Open Label |
Biological: adalimumab
Physicians prescribe adalimumab as per the current label
|
Eligibility| 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:
Contacts and Locations
Show 421 Study Locations
More Information
| Responsible Party: | Abbott Laboratories ( Lawrence McNamee ) |
| Study ID Numbers: | P06-134 |
| Study First Received: | August 31, 2007 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00524537 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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Anti-Inflammatory Agents Digestive System Diseases Gastrointestinal Diseases Therapeutic Uses Crohn Disease Inflammatory Bowel Diseases |
Antirheumatic Agents Adalimumab Intestinal Diseases Gastroenteritis Pharmacologic Actions |