Adalimumab in Adult Japanese Subjects With Psoriasis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 27, 2008

Last Updated Date

October 2, 2009

Start Date ^ICMJE

April 2006

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PASI 50 Response [ Time Frame: Every 4 weeks until Week 40, then every 12 weeks until approval ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00647400 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PASI 75/90 [ Time Frame: Every 4 weeks until Week 40, then every 12 weeks until approval ] [ Designated as safety issue: No ]
Incidence of AEs [ Time Frame: Until Approval ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Adalimumab in Adult Japanese Subjects With Psoriasis

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Biological: adalimumab

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

147

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who completed study M04-688

Exclusion Criteria:

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00647400

Responsible Party

Eiichi Makino, Abbott

Study ID Numbers ^ICMJE

M04-702

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Abbott Japan Co.,Ltd
Eisai Limited

Investigators ^ICMJE

Study Director:

Kazuko Kobayashi

Abbott

Information Provided By

Abbott

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP