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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293709
Recruitment Status : Completed
First Posted : February 17, 2006
Results First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Arthritis, Psoriatic Psoriasis Skin Diseases, Papulosquamous Drug: etanercept

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

Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 2006
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Group/Cohort Intervention/treatment
Patients with Psoriatic Arthritis 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

Primary Outcome Measures :
  1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 52 ]
    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.

Secondary Outcome Measures :
  1. Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52 [ Time Frame: Baseline, Week 52 ]
  2. Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52 [ Time Frame: Baseline, 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).

  3. Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52 [ Time Frame: Baseline, 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.

  4. Change From Baseline in Ritchie Index at Week 52 [ Time Frame: Baseline, 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.

  5. Change From Baseline in Physician Global Assessment of Disease Activity at Week 52 [ Time Frame: Baseline, 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.

  6. Number of Participants With Nail Involvement [ Time Frame: Baseline, Week 12, 52 ]
    Number of participants with psoriatic arthritis affecting the nails are reported.

  7. Change From Baseline in C-reactive Protein (CRP) at Week 52 [ Time Frame: Baseline, 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.

  8. Change From Baseline in Patient Assessment of Itching at Week 52 [ Time Frame: Baseline, Week 52 ]
    Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.

  9. Change From Baseline in Patient Assessment of Pain at Week 52 [ Time Frame: Baseline, Week 52 ]
    Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.

  10. Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52 [ Time Frame: Baseline, 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitive against Etanercept

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293709

Pfizer Investigational Site
Muenchen, Germany, 81377
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00293709     History of Changes
Other Study ID Numbers: 0881A6-102036
First Posted: February 17, 2006    Key Record Dates
Results First Posted: February 26, 2014
Last Update Posted: February 26, 2014
Last Verified: January 2014

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Arthritis, Psoriatic
Skin Diseases
Skin Diseases, Papulosquamous
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors