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

NCT ID: NCT00237887

Last Updated: 2007-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

adalimumab

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Principal Investigators

Beverly Paperiello

Role: STUDY_DIRECTOR

Abbott

References

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.

Reference Type: DERIVED

PMID: 27815915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26547918 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21752491 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18831744 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17936411 (View on PubMed)

Other Identifiers

M03-656

Identifier Type: -

Identifier Source: org_study_id