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| The Safety And Efficacy Of Maintenance Therapy With CP-690,550 |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease |
| This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
| Crohn's Disease |
- Drug: Placebo
oral tablets twice daily - Drug: CP-690,550
oral tablets twice daily
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- Placebo Comparator: Placebo BID
Intervention: Drug: Placebo - Experimental: 5mg BID
Intervention: Drug: CP-690,550 - Experimental: 10mg BID
Intervention: Drug: CP-690,550
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| Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16. |
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| |
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| Completed |
| 180 |
| 90 |
| July 2015 |
| July 2015 (Final data collection date for primary outcome measure) |
Inclusion Criteria: - Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
Exclusion Criteria: - Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
- Subjects likely to require any type of surgery during the study period.
- Fecal culture/toxin assay indicating presence of pathogenic infection.
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| Sexes Eligible for Study: | All |
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| 18 Years to 75 Years (Adult, Older Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Australia, Austria, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Ukraine, United States |
| Croatia, India |
| |
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| NCT01393899 |
A3921084
2011-001754-28 ( EudraCT Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
|
| Pfizer |
| November 2016 |
|
