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
  Purpose

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 Intervention
Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Drug: etanercept

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 129
Study Start Date: January 2006
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Psoriatic Arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitive against Etanercept
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293709

Locations
Germany
Pfizer Investigational Site
Muenchen, Germany, 81377
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00293709     History of Changes
Other Study ID Numbers: 0881A6-102036, B1801126
Study First Received: February 15, 2006
Results First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Skin Diseases
Skin Diseases, Papulosquamous
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014