REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

NCT00127842

Last updated date
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care

- At least one of the following forms of psoriatic arthritis (PsA):

- Distal interphalangeal (DIP) involvement (inflammatory)

- Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis

- Arthritis mutilans

- Asymmetric peripheral arthritis or

- Spinal involvement

- Active psoriatic arthritis at the time of the study enrollment

- Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints

- Greater than 18 years of age at the time of consent

- Able to start etanercept therapy per the approved product monograph

- Informed consent must be provided before any study specific procedures are performed

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Active infections at time of initiating Enbrel® therapy


- Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere
with evaluations of the study medication


- A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the
cervix, within the past 5 years


- Known hypersensitivity to etanercept or any of its components


- Patients receiving, or who have received:


- Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the
previous 3 months or


- Kineret® (anakinra) in the previous 15 days


- Patients receiving or who have received etanercept


- Treatment with any investigational therapy in the 30 days prior to enrollment or
during the study


- Active guttate, erythrodermic or pustular psoriasis at the time of screening


- Presence of any significant and uncontrolled medical condition, which in the
Investigator's opinion, precludes the use of etanercept as outlined in the product
monograph


- Sepsis or at risk of septic syndrome


- Patients not available for follow-up assessment


- Concerns for subject's compliance with the protocol procedures

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Advanced Information
Descriptive Information
Brief Title  ICMJE REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)
Official Title  ICMJE Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
Brief Summary The overall objective of the study was to describe the long-term effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Drug: Etanercept
Administered according to the product monograph by subcutaneous (SC) injection
Other Name: Enbrel®
Study Arms  ICMJE Etanercept
Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
Intervention: Drug: Etanercept
Publications * Gladman DD, Bombardier C, Thorne C, Haraoui B, Khraishi M, Rahman P, Bensen W, Syrotuik J, Poulin-Costello M. Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial. J Rheumatol. 2011 Jul;38(7):1355-62. doi: 10.3899/jrheum.100698. Epub 2011 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2007)
110
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care
  • At least one of the following forms of psoriatic arthritis (PsA):

    • Distal interphalangeal (DIP) involvement (inflammatory)
    • Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
    • Arthritis mutilans
    • Asymmetric peripheral arthritis or
    • Spinal involvement
  • Active psoriatic arthritis at the time of the study enrollment
  • Patients must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints
  • Greater than 18 years of age at the time of consent
  • Able to start etanercept therapy per the approved product monograph
  • Informed consent must be provided before any study specific procedures are performed

Exclusion Criteria:

  • Active infections at time of initiating Enbrel® therapy
  • Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication
  • A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years
  • Known hypersensitivity to etanercept or any of its components
  • Patients receiving, or who have received:

    • Remicade® (infliximab) in the previous 3 months or -- Humira® (adalimumab) in the previous 3 months or
    • Kineret® (anakinra) in the previous 15 days
  • Patients receiving or who have received etanercept
  • Treatment with any investigational therapy in the 30 days prior to enrollment or during the study
  • Active guttate, erythrodermic or pustular psoriasis at the time of screening
  • Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of etanercept as outlined in the product monograph
  • Sepsis or at risk of septic syndrome
  • Patients not available for follow-up assessment
  • Concerns for subject's compliance with the protocol procedures
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00127842
Other Study ID Numbers  ICMJE 20040131
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director:MDAmgen
PRS Account Amgen
Verification Date March 2014

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