Skip to main content
OpenTrials
Completed

NCT Number: NCT00237887

Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject was age 18 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, had moderate to severe plaque psoriasis.
  • Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

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 UVB or PUVA phototherapy
  • Subject cannot avoid excessive sun exposure
  • 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

Adalimumab

Drug

Primary outcomes

  1. Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score

    Time frame: Week 16

Secondary outcomes

  1. Safety parameters

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Important dates

Study start
2004
First posted
Oct 13, 2005
Registry last updated
Aug 29, 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.

Published trials that share one or more normalized conditions with this study.