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

Wyeth

Status and phase: Completed; Phase 4

Conditions: Spondylarthropathies, Enthesitis

Treatments: Drug: Etanercept; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420303

0881A3-404

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Etanercept

B

Placebo Comparator group

Treatment:

Other: Placebo