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Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

Primary Purpose

Spondylarthropathies, Enthesitis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Etanercept
Placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylarthropathies, Enthesitis focused on measuring Refractory Heel Enthesitis in Spondylarthropathy, Spondylarthropathy, Refractory Heel Enthesitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. 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.

Full Information

First Posted
January 8, 2007
Last Updated
July 15, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00420303
Brief Title
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

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylarthropathies, Enthesitis
Keywords
Refractory Heel Enthesitis in Spondylarthropathy, Spondylarthropathy, Refractory Heel Enthesitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
50 mg injection once weekly
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12
Description
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).
Time Frame
12 weeks
Title
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity
Description
A response is defined as at least a 50% improvement (decrease) from baseline in the patient global assessment of disease activity. 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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For France, infomedfrance@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Germany, medinfoDEU@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Netherlands, trials-NL@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Arles
ZIP/Postal Code
13200
Country
France
City
Avignon
ZIP/Postal Code
84000
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Grenoble
ZIP/Postal Code
38130
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice
ZIP/Postal Code
6202
Country
France
City
Orleans
ZIP/Postal Code
45032
Country
France
City
Paris (Bichat)
ZIP/Postal Code
75018
Country
France
City
Paris (COCHIN)
ZIP/Postal Code
75679
Country
France
City
Paris (Pitie Salpetriere)
ZIP/Postal Code
75651
Country
France
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Toulouse
ZIP/Postal Code
31000
Country
France
City
Berlin
ZIP/Postal Code
12200
Country
Germany
City
Herne
ZIP/Postal Code
446652
Country
Germany
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20511606
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.
Results Reference
derived

Learn more about this trial

Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy

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