| A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis
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| A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
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| The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.
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| The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.
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| Interventional
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| Phase 3
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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| Psoriasis
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- Drug: CP-690,550
5 mg oral BID
- Drug: CP-690,550
10 mg oral BID
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Experimental: Active Treatment
The study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market.
All subjects will receive 10 mg BID of CP-690,550 for first 3 months of trial. Study has the option for variable dosing with 5 mg or 10 mg BID after first 3-months of treatment based on PI discretion
Interventions:
- Drug: CP-690,550
- Drug: CP-690,550
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Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13.
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| Terminated
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| 2867
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| 3200
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| June 2016
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| June 2016 (Final data collection date for primary outcome measure)
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Inclusion Criteria:
- Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).
Exclusion Criteria:
- Non-plaque or drug induced forms of psoriasis;
- Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB).
- Any uncontrolled significant medical condition.
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| Sexes Eligible for Study: |
All |
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| 18 Years and older (Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
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| Czech Republic
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| NCT01163253
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A3921061
2010-020002-15 ( EudraCT Number )
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| Yes
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| Not Provided
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| May 2017
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