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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 7, 2005
Last updated: August 28, 2007
Last verified: August 2007
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
Drug: adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Study Director: Beverly Paperiello Abbott
  More Information

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 
Study First Received: October 7, 2005
Last Updated: August 28, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:

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

ClinicalTrials.gov processed this record on May 25, 2016