NCT00338754

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

September 11, 2007

Status Verified

September 1, 2007

First QC Date

June 18, 2006

Last Update Submit

September 10, 2007

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with clinical response relative to Baseline PASI score

Secondary Outcomes (3)

  • QoLs

  • Clinical response indicators

  • Safety parameters

Interventions

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kinki, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Noritaka Inomata, Ph.D.

    Abbott Japan Co.,Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2006

First Posted

June 20, 2006

Study Start

November 1, 2005

Last Updated

September 11, 2007

Record last verified: 2007-09

Locations

JP(8)