A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
NCT01470599
ABOUT THIS STUDY
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- Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
- Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.
- Subjects who have been discontinued due to protocol violation(s) (as determined by the
Sponsor) in the A3921084 study.
- Subjects who were discontinued from the A3921084 study due to an adverse event.
- Subjects likely to require any non-elective surgery or surgery requiring overnight
stay (with the exception of minor same day outpatient procedures that will not
interfere with study drug dosing).
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Descriptive Information | ||||
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Brief Title ICMJE | A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease | |||
Official Title ICMJE | A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease | |||
Brief Summary | The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Panés J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 150 | |||
Original Estimated Enrollment ICMJE | 90 | |||
Actual Study Completion Date ICMJE | July 2016 | |||
Actual Primary Completion Date | July 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 76 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Austria, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Ukraine, United States | |||
Removed Location Countries | Croatia, Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01470599 | |||
Other Study ID Numbers ICMJE | A3921086 2011-003622-27 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | September 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |