Phase 4 N=110 Treatment

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

Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00127842 ↗

Enrolled (actual)

110

Serious AEs

12.7%

Results posted

Apr 2014

Primary outcome: Primary: Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI — 56.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etanercept (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Aug 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Improvement of ≥ 0.50 Units From Baseline to Month 24 in the HAQ DI	56.0	—
SECONDARY Change From Baseline to Month 24 in the Health and Labour Questionnaire (HLQ) Absence From Work Module	0.4	—
SECONDARY Change From Baseline to Month 24 in the HLQ Reduced Productivity at Paid Work Module	0.0	—
SECONDARY Change From Baseline to Month 24 in the HLQ Unpaid Labour Production Module	3.2; 1.9	—
SECONDARY Change From Baseline to Month 24 in the HLQ Impediments to Paid and Unpaid Labour Module	1.5	—
SECONDARY Change From Baseline to Month 24 in the Physician Global Assessment	0.91	—
SECONDARY Percent Change From Baseline to Month 24 in Physician Global Assessment	27.2	—
SECONDARY Change From Baseline to Month 24 in Patient Global Assessment	0.59	—
SECONDARY Percent Change From Baseline to Month 24 in Patient Global Assessment	16.4	—
SECONDARY Percentage of Participants With Improvement of ≥ 75 Percent From Baseline to Month 24 in the Psoriasis Activity and Severity Index (PASI)	41.8	—
SECONDARY Percentage of Participants With a Psoriatic Arthritis Response Criteria (PsARC) Response at Month 24	78.9	—

Summary

The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.

Eligibility 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 psoriatic arthritis (PsA):
Distal interphalangeal (DIP) involvement (inflammatory)
Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
Arthritis mutilans
Asymmetric peripheral arthritis or
Spinal involvement
Active psoriatic arthritis at the time of the study enrollment
Patients 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 etanercept 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 etanercept or any of its components
Patients 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
Patients receiving or who have received etanercept
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 etanercept as outlined in the product monograph
Sepsis or at risk of septic syndrome
Patients not available for follow-up assessment
Concerns for subject's compliance with the protocol procedures

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00127842). 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.