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

This study has been completed.

Sponsors and Collaborators:	Abbott Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00338754

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks	Phase II Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2/3, Randomized, Double-Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Adalimumab in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects with clinical response relative to Baseline PASI score

Secondary Outcome Measures:

QoLs
Clinical response indicators
Safety parameters

Estimated Enrollment:	160
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338754

Locations

Japan

Hokkaido, Japan

Tohoku, Japan

Kanto, Japan

Chubu, Japan

Kyusyu, Japan

Chugoku, Japan

Shikoku, Japan

Kinki, Japan

Sponsors and Collaborators

Abbott

Eisai Limited

Investigators

Study Director:

Noritaka Inomata, Ph.D.

Abbott Japan Co.,Ltd

More Information

Study ID Numbers:	M04-688
Study First Received:	June 18, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00338754
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Skin Diseases
Psoriasis

Adalimumab
Skin Diseases, Papulosquamous
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Therapeutic Uses

Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009