A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
NCT ID: NCT01519089
Last Updated: 2015-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
95 participants
INTERVENTIONAL
2012-03-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CP-690,550 10 mg BID
CP-690,550
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
CP690,550 5 mg BID
CP-690, 550
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
Interventions
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CP-690,550
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
CP-690, 550
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
Eligibility Criteria
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Inclusion Criteria
\[Moderate to Severe Plaque Psoriasis\]
* Diagnosed for at least 12 months.
* Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).
\[Psoriatic Arthritis\]
* Diagnosed for at least 6 months.
* Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
* Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.
Exclusion Criteria
* Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
* any uncontrolled significant medical condition
20 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
JR Sapporo hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Chuo-ku, Kobe, Hyōgo, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan
Nissay Hospital
Osaka, Osaka, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tokyo Teishin Hospital
Chiyoda-ku, Tokyo, Japan
Tokyo medical university Hachioji medical center
Hachiōji, Tokyo, Japan
Kanto Medical Center NTT East Corporation
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo, Japan
Tonami General Hospital
Tonami, Toyama, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Jikei University Hospital
Tokyo, , Japan
Countries
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Related Links
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Other Identifiers
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A3921137
Identifier Type: -
Identifier Source: org_study_id
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