Clinical trial NCT00293722: Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
Official title: Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Keywords: Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 1308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.

Detailed description: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriatic arthritis

Exclusion Criteria:

* Sepsis or risk for sepsis,
* Acute infection,
* Hypersensitivity against Etanercept

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Ritchie Index at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
timeFrame: Baseline, Week 52
measure: Number of Participants With Nail Involvement
timeFrame: Baseline, Week 12, 52
measure: Change From Baseline in C-reactive Protein (CRP) at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Assessment of Itching at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in Patient Assessment of Pain at Week 52
timeFrame: Baseline, Week 52
measure: Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
timeFrame: Baseline, Week 52
Other outcomes:
measure: Change From Baseline in Patient Global Assessment of Disease Activity at Week 52
timeFrame: Baseline, Week 52
Locations:
city: Toerwang-Samerberg
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1.