A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01458574 |
Recruitment Status :
Completed
First Posted : October 25, 2011
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Ulcerative Colitis |
Interventions |
Drug: Placebo Drug: CP690,550 Drug: CP-690,550 |
Enrollment | 593 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo |
---|---|---|---|
Arm/Group Description | Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. |
Period Title: Overall Study | |||
Started | 198 | 197 | 198 |
Treated | 198 | 196 | 198 |
Completed | 111 | 126 | 53 |
Not Completed | 87 | 71 | 145 |
Reason Not Completed | |||
Adverse Event | 5 | 9 | 7 |
Lack of Efficacy | 70 | 53 | 132 |
Lost to Follow-up | 3 | 2 | 1 |
Pregnancy | 1 | 1 | 0 |
Protocol Violation | 0 | 1 | 0 |
Withdrawal by Subject | 6 | 3 | 5 |
Other | 2 | 1 | 0 |
Randomized but not treated | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | Total | |
---|---|---|---|---|---|
Arm/Group Description | Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation. | Total of all reporting groups | |
Overall Number of Baseline Participants | 198 | 197 | 198 | 593 | |
Baseline Analysis Population Description |
Full analysis set (FAS) included all randomized participants.
|
||||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
|||||
Number Analyzed | 198 participants | 197 participants | 198 participants | 593 participants | |
41.9 (13.7) | 42.9 (14.4) | 43.4 (14) | 42.7 (14) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 198 participants | 197 participants | 198 participants | 593 participants | |
Female |
95 48.0%
|
87 44.2%
|
82 41.4%
|
264 44.5%
|
|
Male |
103 52.0%
|
110 55.8%
|
116 58.6%
|
329 55.5%
|
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: | NCT01458574 |
Other Study ID Numbers: |
A3921096 2011-004580-79 ( EudraCT Number ) OCTAVESUSTAIN ( Other Identifier: Alias Study Number ) |
First Submitted: | October 21, 2011 |
First Posted: | October 25, 2011 |
Results First Submitted: | April 7, 2017 |
Results First Posted: | May 18, 2017 |
Last Update Posted: | May 18, 2017 |