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

NCT00237887 | Completed Phase 3

• 1 other identifier: M03-656
• Study Type: interventional
• Target: 1,212
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Psoriasis

Keywords

Psoriasis; adalimumab

Outcome Measures

Primary Outcomes (1)

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

  Week 16

Secondary Outcomes (1)

• Safety parameters

Interventions

adalimumab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Related Publications (5)

• Armstrong AW, Villanueva Quintero DG, Echeverria CM, Gu Y, Karunaratne M, Reyes Servin O. Body Region Involvement and Quality of Life in Psoriasis: Analysis of a Randomized Controlled Trial of Adalimumab. Am J Clin Dermatol. 2016 Dec;17(6):691-699. doi: 10.1007/s40257-016-0229-x.

  PMID: 27815915 DERIVED

• Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.

  PMID: 26547918 DERIVED

• Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol. 2012 Feb;66(2):241-51. doi: 10.1016/j.jaad.2010.12.005. Epub 2011 Jul 14.

  PMID: 21752491 DERIVED

• Revicki DA, Menter A, Feldman S, Kimel M, Harnam N, Willian MK. Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomized, controlled Phase III study. Health Qual Life Outcomes. 2008 Oct 2;6:75. doi: 10.1186/1477-7525-6-75.

  PMID: 18831744 DERIVED

• Menter A, Tyring SK, Gordon K, Kimball AB, Leonardi CL, Langley RG, Strober BE, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. J Am Acad Dermatol. 2008 Jan;58(1):106-15. doi: 10.1016/j.jaad.2007.09.010. Epub 2007 Oct 23.

  PMID: 17936411 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Beverly Paperiello

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 13, 2005
• Study Start: December 1, 2004
• Last Updated: August 29, 2007

Record last verified: 2007-08