ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

This study is currently recruiting participants.
Verified by Abbott, August 2008

Sponsored by: 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
Drug: adalimumab

Genetics Home Reference related topics:   Crohn disease   

MedlinePlus related topics:   Crohn's Disease   

ChemIDplus related topics:   Adalimumab   

U.S. FDA Resources

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)

Further study details as provided by Abbott:

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 Five 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 Five years of Treatment ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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

  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

As per the current approved 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 serious adverse events, adverse events of interest and 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 serious adverse events, adverse events of interest and 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

Contacts
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  Show 275 Study Locations

Sponsors and Collaborators
Abbott

Investigators
Study Director:     Beverly Paperiello     Abbott    
  More Information


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

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Adalimumab
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




Links to all studies - primarily for crawlers