Observational Safety Study of Etanercept (Enbrel) for Treatment of Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00322439
First received: May 5, 2006
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.


Condition Intervention
Psoriasis
Drug: Etanercept

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).


Secondary Outcome Measures:
  • Five-year Cumulative Incidence for Events of Medical Interest (EMIs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    Protocol defined EMIs included: • All malignancies, including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC); • Tuberculosis; • Opportunistic infections treated with intravenous therapy; • Histoplasmosis infections treated with oral antibiotics; • Coccidioidomycosis infections treated with oral antibiotics; • Central nervous system (CNS) demyelinating disorders; • Lupus disease; • Coronary artery disease; • Worsening of psoriasis as defined by change in psoriasis morphology and withdrawal of therapy; • Any event or laboratory abnormality that represents an event of medical significance. Cumulative incidences were calculated using Kaplan-Meier methods where time to event was defined as the time from the first dose of etanercept to the start date of the first occurrence of the event, regardless of exposure (ie, based on observation time). Estimates were adjusted using left truncation methodology to help address any bias due to participants with prior etanercept exposure.

  • Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear) [ Time Frame: Baseline and at 3 and 5 years ] [ Designated as safety issue: No ]
    The sPGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).

  • Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1 [ Time Frame: Baseline and at 3 and 5 years ] [ Designated as safety issue: No ]
    The patient's global assessment of psoriasis is a self-administered numeric scale is designed to evaluate participants' perception of their psoriasis on a scale from 0 (good) to 5 (severe).

  • Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]
    The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A DLQI response is defined as a 5 point improvement from Baseline or a score of 0.

  • Euroqol-5D (EQ-5D) Total Score [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]
    EQ-5D is a self-reported questionnaire that consists of five single-item health domains, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers are recorded as choices of 1, 2, or 3 for each question, with 1 signifying no problem, 2 signifying some problem, and 3 signifying major problem. Using the US scoring algorithm, the possible total EQ-5D score ranges from -0.11 (ie, answered '3' for all questions) to 1.0 (ie, answered '1' for all questions), where 1.0 represents perfect health.

  • Euroqol-5D (EQ-5D) Visual Analog Scale (VAS) [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]
    The EQ-5D visual analog scale (VAS) is a 100 mm scale with 100 representing 'best imaginable health state' and 0 representing 'worst imaginable health state'. Participants were asked to indicate on this scale how good or bad their health was today.

  • Healthcare Resource Use [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]

    This self-administered questionnaire is designed to measure the amount of healthcare resource utilization by the participant in the past 4 weeks. The average answers to the following questions are reported:

    1. How many times have you been to any physician's office or urgent care clinic, not including your dermatologist?
    2. How many times have you seen a nurse practitioner, physician assistant, psychologist, naturopath, acupuncturist, or chiropractor?
    3. How many times have you received care from a health professional (HP) in your home?
    4. How many times have you paid someone to help you do chores around the house (cleaning, maintenance, lawn care)?
    5. How many times have you had a friend or family member take time off work to provide care or transportation?

  • Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]
    The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity (ie, worse outcomes).

  • Percentage of Body Surface Area Affected by Psoriasis [ Time Frame: Baseline, Year 3 and Year 5 ] [ Designated as safety issue: No ]
    Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma.


Enrollment: 2511
Study Start Date: May 2006
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Etanercept
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
Drug: Etanercept
Observational study - no drug administered

Detailed Description:

This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.

Criteria

Inclusion Criteria:

  • Patients with plaque psoriasis

Exclusion Criteria:

  • Prior exposure to any tumor necrosis factor (TNF)-inhibitor
  • Patients for whom Enbrel is contraindicated
  • Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
  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: NCT00322439

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00322439     History of Changes
Other Study ID Numbers: 20040210
Study First Received: May 5, 2006
Results First Received: February 11, 2014
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Amgen:
plaque Psoriasis patients
TNF-inhibitor naïve

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

ClinicalTrials.gov processed this record on October 02, 2014