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OpenTrials
Completed

NCT Number: NCT00338754

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

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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. Proportion of subjects with clinical response relative to Baseline PASI score

Secondary outcomes

  1. QoLs

  2. Clinical response indicators

  3. Safety parameters

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Collaborators

  • Eisai Limited

Registry information

Official study 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

Important dates

Study start
2005
First posted
Jun 20, 2006
Registry last updated
Sep 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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