Adalimumab in Adult Japanese Subjects With Psoriasis - Full Text View

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd Eisai Limited
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00647400

Purpose

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with psoriasis

Condition	Intervention	Phase
Psoriasis	Biological: adalimumab	Phase II Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Open-Label Continuation Study of the Long-Term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis

Further study details as provided by Abbott:

Primary Outcome Measures:

PASI 50 Response [ Time Frame: Until Approval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PASI75/90 [ Time Frame: Until Approval ] [ Designated as safety issue: No ]
Incidence of AEs [ Time Frame: Until Approval ] [ Designated as safety issue: No ]

Enrollment:	147
Study Start Date:	April 2006
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab 40 mg eow: Experimental	Biological: adalimumab Adalimumab 40 mg eow, sc
Adalimumab 80 mg eow: Experimental	Biological: adalimumab Adalimumab 80 mg eow, sc

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647400

Locations

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators

Study Director:

Noritaka Inomata, Ph.D.

Abbott

More Information

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M04-702
Study First Received:	March 27, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00647400
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009