Phase 4 N=24 Randomized Double-blind Treatment

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

Spondylarthropathies, Enthesitis

Bottom Line

View on ClinicalTrials.gov: NCT00420303 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Nov 2009

Primary outcome: Primary: Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12 — -28.54; -11.07 mm — p=0.029

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etanercept (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12	-28.54; -11.07	0.029 sig
PRIMARY Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12	-37.59; -11.58	0.007 sig
SECONDARY Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity	8; 2	0.02 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00420303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.