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Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT00338754

Last Updated: 2007-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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The purpose of the study is to assess the efficacy and safety of repeated administration of adalimumab in adult Japanese subjects with moderate to severe chronic plaque psoriasis.

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

DOUBLE

Interventions

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Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject was age 20 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis

Exclusion Criteria

* Subject had previously received anti-TNF therapy.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVA, UVB or PUVA phototherapy
* Subject is taking or requires oral or injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Limited

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Noritaka Inomata, Ph.D.

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kanto, , Japan

Site Status

Kinki, , Japan

Site Status

Kyusyu, , Japan

Site Status

Shikoku, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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M04-688

Identifier Type: -

Identifier Source: org_study_id