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

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ClinicalTrials.gov Identifier: NCT01470612
Recruitment Status : Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: CP-690,550 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 948 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
Actual Study Start Date : October 1, 2012
Estimated Primary Completion Date : July 27, 2020
Estimated Study Completion Date : July 27, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CP-690,550 5 mg BID
5 mg BID
Drug: CP-690,550
5 mg tablets, BID, for at least 12 months

Experimental: CP-690,550 10 mg BID
10 mg BID
Drug: CP-690,550
10 mg tablets, BID, for at least 12 months




Primary Outcome Measures :
  1. Safety measured by the number of reported adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The proportion of subjects in remission. [ Time Frame: 12 months ]
  2. The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ]
  3. The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ]
  4. The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ]
  5. Number of subjects with serious infections. [ Time Frame: 12 months ]
  6. Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ]
  7. Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ]
  8. Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470612


  Show 308 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470612     History of Changes
Other Study ID Numbers: A3921139
2011-004581-14 ( EudraCT Number )
OCTAVEOPEN ( Other Identifier: Alias Study Number )
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
Ulcerative colitis
open-label
long term treatment

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action