Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists

Psoriasis Clinical Trial

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 Dermatologists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293709
• Other study ID #: 0881A6-102036
• Secondary ID: B1801126
• Status: Completed
• Phase: N/A
• First received: February 15, 2006
• Last updated: January 10, 2014
• Start date: January 2006
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

• Sepsis or risk for sepsis,

• Acute infection,

• Hypersensitive against Etanercept

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriasis
• Skin Diseases
• Skin Diseases, Papulosquamous

Intervention

Drug:
• etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Muenchen

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.	Baseline up to Week 52	Yes
Secondary	Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52		Baseline, Week 52	No
Secondary	Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52	PASI: combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections (head, arms, trunk, and legs); each area was scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI=sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4; total score ranged from 0 (no disease) to 72 (maximal disease).	Baseline, Week 52	No
Secondary	Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.	Baseline, Week 52	No
Secondary	Change From Baseline in Ritchie Index at Week 52	Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.	Baseline, Week 52	No
Secondary	Change From Baseline in Physician Global Assessment of Disease Activity at Week 52	Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.	Baseline, Week 52	No
Secondary	Number of Participants With Nail Involvement	Number of participants with psoriatic arthritis affecting the nails are reported.	Baseline, Week 12, 52	No
Secondary	Change From Baseline in C-reactive Protein (CRP) at Week 52	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 52	No
Secondary	Change From Baseline in Patient Assessment of Itching at Week 52	Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.	Baseline, Week 52	No
Secondary	Change From Baseline in Patient Assessment of Pain at Week 52	Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.	Baseline, Week 52	No
Secondary	Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52	SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts : physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.	Baseline, Week 52	No

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