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

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


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

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
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Please refer to this study by its identifier: NCT00573794

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

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

Keywords provided by AbbVie:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on April 21, 2017