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

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

Official 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

Conditions
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Spondylarthropathies, Enthesitis

Intervention / Treatment
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* Drug: Etanercept
* Other: Placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Etanercept<br>* 50 mg injection once weekly<br>|
| Placebo Comparator: B<br> | Other: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Heel Enthesitis in Spondylarthropathy, Spondylarthropathy, Refractory Heel Enthesitis