Status:
COMPLETED
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Spondylarthropathies, Enthesitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00420303
Start Date
January 1 2007
End Date
September 1 2008
Last Update
July 20 2010
Active Locations (15)
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1
Arles, France, 13200
2
Avignon, France, 84000
3
Bordeaux, France, 33076
4
Grenoble, France, 38130