Phase 4 N=752 Randomized Single-blind Treatment

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00245960 ↗

Enrolled (actual)

752

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis — 176; 119 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: etanercept (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis	176; 119	—
SECONDARY Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	284; 282; 303; 299	—

Summary

The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

Eligibility Criteria

Inclusion Criteria

18 years of age or older at time of consent
Active Psoriatic Arthritis
Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria

Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
Prior exposure to any TNF-inhibitor, including etanercept

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00245960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.