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Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis (OCTAVE)

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470612
First received: October 21, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes

October 21, 2011
May 2, 2013
October 2012
November 2017   (final data collection date for primary outcome measure)
Safety measured by the number of reported adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01470612 on ClinicalTrials.gov Archive Site
  • The proportion of subjects in remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • The proportion of subjects in remission over time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects in partial Mayo score remission over time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve mucosal healing over time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170 over time. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: CP-690,550
    5 mg tablets, BID, for at least 12 months
  • Drug: CP-690,550
    10 mg tablets, BID, for at least 12 months
  • Experimental: CP-690,550 5 mg BID
    5 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550 10 mg BID
    10 mg BID
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
725
December 2017
November 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
  • Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

  • Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Austria,   Belgium,   Denmark,   Estonia,   Germany,   Japan,   Korea, Republic of,   Latvia,   New Zealand,   Slovakia,   South Africa
 
NCT01470612
A3921139
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

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