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

NCT00322439 | Completed Results

• 1 other identifier: 20040210
• Study Type: observational
• Target: 2,511
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Psoriasis

Keywords

plaque Psoriasis patients; TNF-inhibitor naïve

Outcome Measures

Primary Outcomes (1)

• Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events

  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).

  5 years

Secondary Outcomes (9)

• Five-year Cumulative Incidence for Events of Medical Interest (EMIs)

  5 years

• Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)

  Baseline and at 3 and 5 years

• Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1

  Baseline and at 3 and 5 years

• Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response

  Baseline, Year 3 and Year 5

• Euroqol-5D (EQ-5D) Total Score

  Baseline, Year 3 and Year 5

Study Arms (1)

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

Interventions

Etanercept DRUG

Observational study - no drug administered

Etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with plaque psoriasis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Creamer K, McCroskery P, Kricorian G, Gelfand JM. OBSERVE-5, an Observational Post-Marketing SafetySurveillance Registry of Etanercept for the treatment of Psoriasis: A Model for Studying New Psoriasis Therapies. Psoriasis Forum. 2010;16(3):3-7.

  BACKGROUND

• Kimball AB, Pariser D, Yamauchi PS, Menter A, Teller CF, Shi Y, Yong M, Creamer K, Hooper M, Aras G, Kricorian G, Gelfand JM. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013 May;68(5):756-64. doi: 10.1016/j.jaad.2012.10.055. Epub 2013 Jan 26.

  PMID: 23357569 BACKGROUND

• Kimball AB, Rothman KJ, Kricorian G, Pariser D, Yamauchi PS, Menter A, Teller CF, Aras G, Accortt NA, Hooper M, Rice KC, Gelfand JM. OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results. J Am Acad Dermatol. 2015 Jan;72(1):115-22. doi: 10.1016/j.jaad.2014.08.050. Epub 2014 Sep 26.

  PMID: 25264239 BACKGROUND

• Kimball AB, Schenfeld J, Accortt NA, Anthony MS, Rothman KJ, Pariser D. Incidence rates of malignancies and hospitalized infectious events in patients with psoriasis with or without treatment and a general population in the U.S.A.: 2005-09. Br J Dermatol. 2014 Feb;170(2):366-73. doi: 10.1111/bjd.12744.

  PMID: 24251402 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma.

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2006
• First Posted: May 8, 2006
• Study Start: May 1, 2006
• Primary Completion: December 11, 2012
• Study Completion: February 8, 2013
• Last Updated: June 28, 2018
• Results First Posted: March 26, 2014

Record last verified: 2018-05