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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00420303 |
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Date of registration:
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08/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
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Scientific title:
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A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00420303 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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France
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Germany
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Netherlands
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, medinfoDEU@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion criteria
- Spondylarthropathy
- Heel enthesitis refractory to standard treatment
- Between 18 and 70 years of age
- The patient global assessment of the disease activity (measured by a 100 mm VAS) must
be >40 in the last 48 hours
Exclusion criteria
- Use of > 1 local steroid injection within 2 weeks of screening
- Prior exposure to any TNF-inhibitor, including etanercept
- Dose of NSAIDs changed within two weeks of study drug evaluation
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spondylarthropathies, Enthesitis
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Intervention(s)
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Drug: Etanercept
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Other: Placebo
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Primary Outcome(s)
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Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
[Time Frame: 12 weeks]
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Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
[Time Frame: 12 weeks]
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Secondary ID(s)
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0881A3-404
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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