A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD) - Full Text View

A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD) (PYRAMID)

This study is ongoing, but not recruiting participants.

First Received on August 31, 2007. Last Updated on May 18, 2012 History of Changes

Sponsor:	Abbott
Information provided by (Responsible Party):	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:	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 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 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 ]

Enrollment:	5068
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: ABT-D2E7 adalimumab Humira®

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 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 427 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Roopal B Thakkar, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00524537 History of Changes
Other Study ID Numbers:	P06-134
Study First Received:	August 31, 2007
Last Updated:	May 18, 2012
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - French Health Products Safety Agency Germany: Paul-Ehrlich-Institut Greece: Ministry of Health and Welfare Hungary: National Institute of Pharmacy Iceland: Icelandic Medicines Control Agency Ireland: Irish Medicines Board Italy: The Italian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) New Zealand: Medsafe Norway: Norwegian Medicines Agency Portugal: National Pharmacy and Medicines Institute Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health South Africa: Medicines Control Council Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Abbott:

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 22, 2012