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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00573794
First received: December 12, 2007
Last updated: April 8, 2014
Last verified: April 2014

December 12, 2007
April 8, 2014
November 2007
June 2014   (final data collection date for primary outcome measure)
  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
Complete list of historical versions of study NCT00573794 on ClinicalTrials.gov Archive Site
  • 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 ] [ 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; Week 240; Week 292; Week 340 and Week 388 ] [ Designated as safety issue: No ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ] [ Designated as safety issue: No ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Throughout course of the study ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
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

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
Biological: adalimumab
Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous
Other Name: ABT-D2E7 HUMIRA
Experimental: 40 mg EOW or 40 mg weekly
Intervention: Biological: adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
800
May 2016
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   New Zealand,   Poland,   Puerto Rico,   Slovakia,   Spain,   Sweden,   Switzerland
 
NCT00573794
M10-223, 2007-004157-28
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Andreas Lazar, MD AbbVie
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP