REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®

Condition(s) targeted: Psoriatic Arthritis

Intervention: Enbrel® (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

The primary objective of the study is to estimate the proportion of psoriatic arthritis (PsA) subjects achieving a greater than 0. 50 unit improvement from baseline in the Healthcare Quality Assurance (HQA) disability index at month 24. Given a sample size of 125 subjects, the precision of the estimate, as reflected by the width of the 95% confidence interval, will not exceed 0. 176 units.

Official title: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Describe long term effectiveness of Enbrel® in subjects with PsA as measured by the Health Assessment Questionnaire Disability Index (HAQDI)

Secondary outcome: Describe long term productivity of Enbrel® in subjects with PsA in Canadian clinical practice

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: - Presence of psoriasis or previous evidence of psoriasis documented by

a dermatologist as part of usual care - At least one of the following forms of PsA:

1. Distal interphalangeal (DIP) involvement (inflammatory)

2. Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis

3. Arthritis mutilans

4. Asymmetric peripheral arthritis or

5. Spinal involvement - Active psoriatic arthritis at the time of the study enrollment -

Subjects must demonstrate greater than 3 swollen joints and greater than 3

tender/painful joints - Greater than 18 years of age at the time of consent - Able to

start Enbrel® therapy per the approved product monograph - Informed consent must be

provided before any study specific procedures are performed Exclusion Criteria: -

Active infections at time of initiating Enbrel® therapy - Evidence of skin conditions

(e. g., eczema) other than psoriasis that would interfere with evaluations of the study

medication - A malignancy, other than basal cell carcinoma of the skin or, in situ

carcinoma of the cervix, within the past 5 years - Known hypersensitivity to Enbrel®

or any of its components - Subjects receiving, or who have received: * Remicade®

(infliximab) in the previous 3 months or * Humira® (adalimumab) in the previous 3

months or * Kineret® (anakinra) in the previous 15 days - Subjects receiving or who

have received Enbrel® - Treatment with any investigational therapy in the 30 days

prior to enrollment or during the study - Active guttate, erythrodermic or pustular

psoriasis at the time of screening - Presence of any significant and uncontrolled

medical condition, which in the Investigator's opinion, precludes the use of Enbrel®

as outlined in the product monograph - Sepsis or at risk of septic syndrome - Subjects

not available for follow-up assessment - Concerns for subject's compliance with the

protocol procedures

AmgenTrials clinical trials website

Clinical Study Results website

Starting date: August 2005
Ending date: May 2009
Last updated: March 6, 2008