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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00293709
First received: February 15, 2006
Last updated: January 10, 2014
Last verified: January 2014

February 15, 2006
January 10, 2014
January 2006
February 2013   (final data collection date for primary outcome measure)
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 52 ] [ Designated as safety issue: Yes ]
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.
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Complete list of historical versions of study NCT00293709 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
  • Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Ritchie Index at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Nail Involvement [ Time Frame: Baseline, Week 12, 52 ] [ Designated as safety issue: No ]
    Number of participants with psoriatic arthritis affecting the nails are reported.
  • Change From Baseline in C-reactive Protein (CRP) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Patient Assessment of Itching at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
  • Change From Baseline in Patient Assessment of Pain at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
  • Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 [ Time Frame: Baseline, Week 52 ] [ Designated as safety issue: No ]
    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.
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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
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

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

  • Arthritis, Psoriatic
  • Psoriasis
  • Skin Diseases, Papulosquamous
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.
Other Name: Enbrel
Patients with Psoriatic Arthritis
Intervention: Drug: etanercept
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitive against Etanercept
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00293709
0881A6-102036, B1801126
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP