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

This study is currently recruiting participants.
Verified September 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470612
First Posted: November 11, 2011
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
October 21, 2011
November 11, 2011
September 12, 2017
October 1, 2012
July 27, 2018   (Final data collection date for primary outcome measure)
Safety measured by the number of reported adverse events [ Time Frame: 12 months ]
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 ]
  • The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ]
  • The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ]
  • The proportion of subjects in remission over time. [ Time Frame: 12 months ]
  • The proportion of subjects in partial Mayo score remission over time. [ Time Frame: 12 months ]
  • The proportion of subjects who achieve mucosal healing over time. [ Time Frame: 12 months ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170 over time. [ Time Frame: 12 months ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ]
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
Intervention Model: Parallel Assignment
Masking: None (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
900
July 27, 2018
July 27, 2018   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Australia,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Czech Republic,   India
 
NCT01470612
A3921139
2011-004581-14 ( EudraCT Number )
OCTAVEOPEN ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

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