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

Sponsored by:	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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune

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

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 Study Completion Date:	July 2012
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:

Bola Akinlade, MD

Abbott

More Information

Responsible Party:	Abbott ( Beverly Paperiello, Director Immunology Clinical Program Management )
Study ID Numbers:	M10-223
Study First Received:	December 12, 2007
Last Updated:	July 15, 2008
ClinicalTrials.gov Identifier:	NCT00573794
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Ulcerative Colitis

Study placed in the following topic categories:

Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Adalimumab

Antibodies, Monoclonal
Antibodies
Digestive System Diseases
Gastroenteritis
Colitis
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathologic Processes
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009