Long-Term Safety and Tolerability Study in Subjects With Crohn's Disease - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00195715

Purpose

The purpose of the study is to assess the long-term safety of adalimumab in subjects with Crohn's Disease

Condition	Intervention	Phase
Crohn's Disease	Biological: adalimumab	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Further study details as provided by Abbott:

Primary Outcome Measures:

Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ), and 36-Item Short Form (SF-36) [ Time Frame: Ongoing up through Week 240/ET ] [ Designated as safety issue: No ]
Safety parameters - Labs, Adverse Events [ Time Frame: Ongoing up through Week 240/ET ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Reported Outcomes [ Time Frame: Ongoing up through Week 240/ET ] [ Designated as safety issue: No ]

Enrollment:	865
Study Start Date:	September 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open-Label: Experimental Every Week Dosing and Every Other Week Dosing	Biological: adalimumab adalimumab 40 mg every other week Biological: adalimumab adalimumab 40 mg every week

Eligibility

Criteria

Inclusion Criteria:

Subject must have successfully enrolled in and completed a previous Crohn's adalimumab study.
Subject is judged to be in generally good health as determined by the principal investigator throughout the preceding Crohn's disease study

Exclusion Criteria:

Subjects who did not complete a previous Crohn's adalimumab study.
Subjects on prednisone > 40 mg/day (or equivalent), subjects on budesonide > 9 mg/day, or subjects currently taking both budesonide and prednisone (or equivalent) are excluded.
Subject considered by the investigator, for any reason, to be an unsuitable candidate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195715

Locations

United States, Illinois
Global Medical Information-Abbott Laboratories
Abbott Park, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Global Medical Information

Abbott

More Information

Responsible Party:	Abbott ( Barry Bittle )
Study ID Numbers:	M04-690
Study First Received:	September 13, 2005
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00195715
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease

Inflammatory Bowel Diseases
Adalimumab
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009