Phase 4
Completed N=24
Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
Spondylarthropathies, Enthesitis
Source: ClinicalTrials.gov NCT00420303 ↗
Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Nov 2009
Primary outcomePrimary: 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
Summary
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
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 |
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
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. Informational only — not medical advice.