Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy
1 other identifier
interventional
24
3 countries
15
Brief Summary
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2007
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 8, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
November 10, 2009
CompletedJuly 20, 2010
July 1, 2010
1.7 years
January 8, 2007
September 30, 2009
July 15, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
PGA was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. The normalized net incremental area under the curve of the PGA is the area between the baseline and the PGA curve as a function of time (week 2, 4, 8, 12). AUC was computed using the linear trapezoidal method. All the areas above the baseline and under the curve are positive and all the area below the baseline and above the curve are negative. The net incremental AUC is the sum of these areas. This result is then divided by the study duration of the patients. (negative value = improvement).
12 weeks
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
The patient global assessment of disease activity was measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Change=12 week score minus baseline score. A negative score indicates an improvement in disease activity and a positive score indicates worsening.
Baseline and 12 weeks
Secondary Outcomes (1)
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
12 weeks
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Arles, 13200, France
Unknown Facility
Avignon, 84000, France
Unknown Facility
Bordeaux, 33076, France
Unknown Facility
Grenoble, 38130, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Nice, 6202, France
Unknown Facility
Orléans, 45032, France
Unknown Facility
Paris (Bichat), 75018, France
Unknown Facility
Paris (cochin), 75679, France
Unknown Facility
Paris (Pitie Salpetriere), 75651, France
Unknown Facility
Strasbourg, 67098, France
Unknown Facility
Toulouse, 31000, France
Unknown Facility
Berlin, 12200, Germany
Unknown Facility
Herne, 446652, Germany
Unknown Facility
Maastricht, 6229 HX, Netherlands
Related Publications (1)
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.
PMID: 20511606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For France, infomedfrance@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, medinfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Netherlands, trials-NL@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2007
First Posted
January 11, 2007
Study Start
January 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 20, 2010
Results First Posted
November 10, 2009
Record last verified: 2010-07