A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis (OCTAVE)
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ClinicalTrials.gov Identifier: NCT01465763 |
Recruitment Status :
Completed
First Posted : November 6, 2011
Results First Posted : June 7, 2016
Last Update Posted : June 7, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Ulcerative Colitis |
Interventions |
Drug: tofacitinib Drug: Placebo |
Enrollment | 614 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | Participants were randomized to tofacitinib 10 milligram (mg) or placebo twice a day (BID)(4:1 ratio) after protocol amendment 3, which removed tofacitinib 15 mg BID. Due to low participant numbers, tofacitinib 15 mg BID was excluded from efficacy analyses, but was included in participant flow, baseline characteristics and adverse events analyses. |
Arm/Group Title | Tofacitinib 10 mg BID | Tofacitinib 15 mg BID | Placebo BID |
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Arm/Group Description | Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period. | Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period. | Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period. |
Period Title: Overall Study | |||
Started | 476 | 16 | 122 |
Completed | 445 | 15 | 118 |
Not Completed | 31 | 1 | 4 |
Reason Not Completed | |||
Withdrawal by Subject | 4 | 0 | 1 |
Insufficient Clinical Response | 11 | 0 | 1 |
Adverse Event | 9 | 0 | 1 |
Other | 2 | 0 | 0 |
Protocol Violation | 4 | 1 | 1 |
Death | 1 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Tofacitinib 10 mg BID | Tofacitinib 15 mg BID | Placebo BID | Total | |
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Arm/Group Description | Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period. | Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period. | Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period. | Total of all reporting groups | |
Overall Number of Baseline Participants | 476 | 16 | 122 | 614 | |
Baseline Analysis Population Description |
The safety analysis set consists of all randomized participants who received at least 1 dose of study medication.
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 476 participants | 16 participants | 122 participants | 614 participants |
18 to 44 Years | 295 | 11 | 72 | 378 | |
45 to 64 Years | 145 | 4 | 39 | 188 | |
Greater Than or Equal to (>=) 65 Years | 36 | 1 | 11 | 48 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 476 participants | 16 participants | 122 participants | 614 participants | |
Female |
199 41.8%
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7 43.8%
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45 36.9%
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251 40.9%
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Male |
277 58.2%
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9 56.3%
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77 63.1%
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363 59.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: | Pfizer ClinicalTrials.gov Call Center |
Organization: | Pfizer Inc. |
Phone: | 1-800-718-1021 |
EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01465763 |
Other Study ID Numbers: |
A3921094 2011-004578-27 ( EudraCT Number ) OCTAVEINDUCTION1 ( Other Identifier: Alias Study Number ) |
First Submitted: | October 21, 2011 |
First Posted: | November 6, 2011 |
Results First Submitted: | May 1, 2016 |
Results First Posted: | June 7, 2016 |
Last Update Posted: | June 7, 2016 |