A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00524537
First received: August 31, 2007
Last updated: April 19, 2013
Last verified: April 2013
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD) |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Adalimumab
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- The primary objective of this Registry study is to evaluate the long-term safety of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six Years of Treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary objective is to evaluate long-term effectiveness of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six years of Treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 5000 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Open Label |
Biological: adalimumab
Physicians prescribe adalimumab as per the current label
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Crohn's patients who have been prescribed adalimumab according to the local label
Criteria
Inclusion Criteria:
- Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbott sponsored investigational CD trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
- Subjects who were participants in Abbott sponsored investigational Crohn's disease trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
- Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
- Subjects willing to consent to data being collected and provided to Abbott.
- Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.
Exclusion Criteria:
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524537
Show 426 Study Locations
Show 426 Study LocationsSponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Roopal B Thakkar, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT00524537 History of Changes |
| Other Study ID Numbers: | P06-134 |
| Study First Received: | August 31, 2007 |
| Last Updated: | April 19, 2013 |
| Health Authority: | Slovakia: State Institute for Drug Control Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency Iceland: Icelandic Medicines Control Agency Denmark: Danish Medicines Agency Sweden: Medical Products Agency Portugal: National Pharmacy and Medicines Institute Hungary: National Institute of Pharmacy Italy: The Italian Medicines Agency Germany: Paul-Ehrlich-Institut Norway: Norwegian Medicines Agency Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Ireland: Irish Medicines Board South Africa: Medicines Control Council New Zealand: Medsafe Czech Republic: State Institute for Drug Control Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment United States: Food and Drug Administration Belgium: Federal Agency for Medicinal Products and Health Products Spain: Agencia Española de Medicamentos y Productos Sanitarios Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Slovenia: Agency for Medicinal Products - Ministry of Health Greece: Ministry of Health and Welfare France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by AbbVie:
|
Crohn's Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013