Study Evaluating Etanercept for the Treatment of Refractory Heel Enthesitis in Spondylarthropathy
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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
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 May 16, 2013