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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00573794
First received: December 12, 2007
Last updated: January 3, 2017
Last verified: January 2017
  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 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, 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:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192, Week 240; Week 292 Week 340, Week 388, ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ]

Secondary Outcome Measures:
  • Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ]
  • Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292; Week 340; Week 388, ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Throughout course of the study ]

Enrollment: 592
Study Start Date: November 2007
Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg EOW or 40 mg weekly Biological: adalimumab
Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous
Other Names:
  • ABT-D2E7
  • HUMIRA

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 133 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Andreas Lazar, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00573794     History of Changes
Other Study ID Numbers: M10-223  2007-004157-28 
Study First Received: December 12, 2007
Last Updated: January 3, 2017

Keywords provided by AbbVie:
Ulcerative Colitis

Additional relevant MeSH terms:
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 24, 2017