A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Axial Spondyloarthritis
Intervention: etanercept (Drug); etanercept (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of
etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Clinical Details
Official title: A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To compare the NSAID sparing effect of etanercept with that of placebo in adult subjects with axial involvement of SpA after 8 weeks of active treatment in comparison to Baseline (NSAID ASAS score).
Secondary outcome: The area under the curve (AUC) between randomization and Week 8 for the NSAID ASAS score.The efficacy of etanercept for symptom control compared with that of placebo at Weeks 4 and 8. The change in concomitant NSAID treatment requirement between Baseline and Week 16 in the group originally receiving etanercept. The change in concomitant NSAID treatment requirement between Week 8 and Week 16 in the group originally receiving placebo The efficacy of etanercept in the group receiving etanercept from Baseline up to Week 16. The change in efficacy in the group originally receiving placebo group from Week 8 to Week 16 The safety and tolerability of etanercept in this subject population
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female subjects aged 18 years and over at the time of consent to the study.
- Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
- Axial involvement refractory to previous or current intake of NSAIDs, defined as at
least 2 NSAIDs at maximum tolerated dose determined from past medical history taken
for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
- Active axial involvement defined by mini BASDAI
Exclusion Criteria:
- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
- Subjects who have received any previous treatment with etanercept or other TNFα
inhibitors or biologic agents.
- Subjects with a known or expected allergy, contraindication, or hypersensitivity to
etanercept or its excipients.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Institut Calot - Fondation Hopale, Berck-sur-Mer 62608, France; Recruiting
Hopital Pellegrin, Bordeaux Cedex 33076, France; Recruiting
Centre Hospitalier, Service de Rhumatologie, Cahors 46000, France; Recruiting
CHU Hopital Gabriel Montpied, Clermont-Ferrand 63003, France; Recruiting
Centre Hospitalier Sud Francilien, Corbeil Essonnes 91100, France; Recruiting
Hopital Bicetre, LE KREMLIN-BICETRE Cedex 94275, France; Recruiting
CH Le Mans, Le Mans 72037, France; Recruiting
Chu Dupuytren, Rhumatologie et Therapeutique, Limoges 87042, France; Recruiting
CHU Lapeyronie, Immuno-Rhumatologie, Montpellier 34000, France; Recruiting
Hopital de l'Archet, Nice 06202, France; Recruiting
Hopital Porte Madeleine, Orleans Cedex 1 45032, France; Recruiting
Hopital Bichat, Paris 75018, France; Recruiting
Hopital Saint Joseph - Service de Rhumatologie, Paris 75014, France; Recruiting
Hopital Cochin, Paris 75014, France; Recruiting
Hôpital Saint-Antoine, Paris 75012, France; Recruiting
Service de Rhumatologie, Paris 75651 Cedex 13, France; Recruiting
CHU Bois Guillaume - Service de Rhumatologie, Rouen 76031, France; Recruiting
CHU de Saint Etienne, Hopital Nord, Saint Etienne Cedex 2 42055, France; Recruiting
Hopital Purpan, Toulouse Cedex 09 31059, France; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2011
Last updated: January 16, 2013
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