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Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
This study has been completed.
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00237887
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: adalimumab
Phase III

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • Safety parameters

Enrollment: 1212
Study Start Date: December 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237887

Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott
  More Information

Publications indexed to this study:
Study ID Numbers: M03-656
Study First Received: October 7, 2005
Last Updated: August 28, 2007
ClinicalTrials.gov Identifier: NCT00237887  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Psoriasis
adalimumab

Study placed in the following topic categories:
Skin Diseases
Psoriasis
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009