A 5-Year Registry Study of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

This study is ongoing, but not recruiting participants.

First Received: August 31, 2007 Last Updated: January 13, 2010 History of Changes

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)

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 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:	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

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

Show 421 Study Locations

Sponsors and Collaborators

Abbott

More Information

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Crohn Disease
Inflammatory Bowel Diseases

Antirheumatic Agents
Adalimumab
Intestinal Diseases
Gastroenteritis
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010