Clinical trial NCT00420303: Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Official title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylarthropathies, Enthesitis
Keywords: Refractory Heel Enthesitis in Spondylarthropathy
Spondylarthropathy
Refractory Heel Enthesitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.


Eligibility criteria: 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

Primary outcomes:
measure: Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
timeFrame: 12 weeks
measure: Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Arles
country: France
city: Avignon
country: France
city: Bordeaux
country: France
city: Grenoble
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Orleans
country: France
city: Paris (Bichat)
country: France
city: Paris (COCHIN)
country: France
city: Paris (Pitie Salpetriere)
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Herne
country: Germany
city: Maastricht
country: Netherlands
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougados M, Combe B, Braun J, Landewe R, Sibilia J, Cantagrel A, Feydy A, van der Heijde D, Leblanc V, Logeart I. A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial. Ann Rheum Dis. 2010 Aug;69(8):1430-5. doi: 10.1136/ard.2009.121533. Epub 2010 May 28.