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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-01-31

Brief Summary

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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 plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CP-690,550 10 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

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

Group Type EXPERIMENTAL

CP-690, 550

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Are 20 years or older and considered to be candidates for systemic or phototherapy.

\[Moderate to Severe Plaque Psoriasis\]

* 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

* Non-plaque or drug induced forms of psoriasis
* Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
* any uncontrolled significant medical condition
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Site Status

JR Sapporo hospital

Sapporo, Hokkaido, Japan

Site Status

Kobe University Hospital

Chuo-ku, Kobe, Hyōgo, Japan

Site Status

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, Japan

Site Status

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, Japan

Site Status

University of Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Site Status

Nissay Hospital

Osaka, Osaka, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status

Tokyo Teishin Hospital

Chiyoda-ku, Tokyo, Japan

Site Status

Tokyo medical university Hachioji medical center

Hachiōji, Tokyo, Japan

Site Status

Kanto Medical Center NTT East Corporation

Shinagawa-ku, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjyuku-ku, Tokyo, Japan

Site Status

Tonami General Hospital

Tonami, Toyama, Japan

Site Status

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

Site Status

Jikei University Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

Other Identifiers

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A3921137

Identifier Type: -

Identifier Source: org_study_id

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