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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00420303
First received: January 8, 2007
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Spondylarthropathies, Enthesitis
Drug: Etanercept
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Patient Global Assessment of Disease Activity Score at Week 12 [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Number of Patients Achieving a 50% Response on the Patient Global Assessment of Disease Activity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Etanercept
50 mg injection once weekly
Placebo Comparator: B Other: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420303

Locations
France
Arles, France, 13200
Avignon, France, 84000
Bordeaux, France, 33076
Grenoble, France, 38130
Montpellier, France, 34295
Nice, France, 6202
Orleans, France, 45032
Paris (Bichat), France, 75018
Paris (COCHIN), France, 75679
Paris (Pitie Salpetriere), France, 75651
Strasbourg, France, 67098
Toulouse, France, 31000
Germany
Berlin, Germany, 12200
Herne, Germany, 446652
Netherlands
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00420303     History of Changes
Other Study ID Numbers: 0881A3-404
Study First Received: January 8, 2007
Results First Received: September 30, 2009
Last Updated: July 15, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Independent Ethics Committee
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Refractory Heel Enthesitis in Spondylarthropathy
Spondylarthropathy
Refractory Heel Enthesitis

Additional relevant MeSH terms:
Spondylarthropathies
Tendinopathy
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014