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

Phase 4

Completed

• Conditions: Spondylarthropathies, Enthesitis
• Interventions: Drug: Etanercept; Other: Placebo

• Registration Number: NCT00420303
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-30
• Results First Submitted QC: 2009-10-05
• Results First Posted: 2009-11-10
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-15
• Last Update Posted: 2010-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Etanercept	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12	Baseline and 12 weeks	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.
Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity	12 weeks	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.