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Completed

NCT Number: NCT00420303

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

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

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Key information

Conditions

Spondylarthropathies, Enthesitis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arles, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

50 mg injection once weekly

Placebo

Other

placebo

Primary outcomes

  1. Normalized Net Incremental Area Under the Curve (AUC) for Patient Global Assessment of Disease Activity (PGA) Between Randomization and Week 12

    Time frame: 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).

  2. Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12

    Time frame: 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.

Secondary outcomes

  1. Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 11, 2007
Registry last updated
Jul 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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