Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00573794

Purpose

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis

Condition	Intervention	Phase
Ulcerative Colitis	Biological: adalimumab	Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, 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 Ulcerative Colitis

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Adalimumab

Further study details as provided by Abbott:

Primary Outcome Measures:

Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ] [ Designated as safety issue: No ]
Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ] [ Designated as safety issue: No ]
Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ] [ Designated as safety issue: No ]
Cumulative number of unscheduled outpatient visits [ Time Frame: Week 48, Week 96, Week 144, Week 192 and Week 240 ] [ Designated as safety issue: No ]
AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	November 2007
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
40 mg EOW or 40 mg weekly: Experimental	Biological: adalimumab Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous

Eligibility

Criteria

Inclusion Criteria:

Subject must have successfully enrolled in and completed either the M06-826 study or the M06-827 study.
Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
Subject considered by the investigator, for any reason, to be an unsuitable candidate
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573794

Locations

United States, Illinois
Abbott Global Medical Information
North Chicago, Illinois, United States, 60064

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Andreas Lazar, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Beverly Paperiello, Director Immunology Clinical Program Management )
Study ID Numbers:	M10-223
Study First Received:	December 12, 2007
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00573794 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Ulcerative Colitis

Additional relevant MeSH terms:

Ulcer
Colitis
Colitis, Ulcerative
Adalimumab
Anti-Inflammatory Agents
Gastrointestinal Diseases
Colonic Diseases
Inflammatory Bowel Diseases

Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Gastroenteritis
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 20, 2009