Back to resultsAdalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Proportion of subjects with clinical response relative to Baseline PASI score
Secondary Outcome Measures
QoLs
Clinical response indicators
Safety parameters
Full Information
NCT ID
NCT00338754
First Posted
June 18, 2006
Last Updated
September 10, 2007
Sponsor
Abbott
Collaborators
Eisai Limited
1. Study Identification
Unique Protocol Identification Number
NCT00338754
Brief Title
Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
Collaborators
Eisai Limited
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Human anti-TNF monoclonal antibody adalimumab/ up to 24 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects with clinical response relative to Baseline PASI score
Secondary Outcome Measure Information:
Title
QoLs
Title
Clinical response indicators
Title
Safety parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noritaka Inomata, Ph.D.
Organizational Affiliation
Abbott Japan Co.,Ltd
Official's Role
Study Director
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kanto
Country
Japan
City
Kinki
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Tohoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Adalimumab in Adult Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
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