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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237887
• Other study ID #: M03-656
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: August 28, 2007
• Start date: December 2004

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1212
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• adalimumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score		Week 16
Secondary	Safety parameters