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

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ClinicalTrials.gov Identifier: NCT00237887
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : August 29, 2007
Sponsor:
Information provided by:
Abbott

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

Condition or disease Intervention/treatment Phase
Psoriasis Drug: adalimumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Safety parameters


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00237887


Sponsors and Collaborators
Abbott
Investigators
Study Director: Beverly Paperiello Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00237887     History of Changes
Other Study ID Numbers: M03-656
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: August 29, 2007
Last Verified: August 2007

Keywords provided by Abbott:
Psoriasis
adalimumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents