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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

Page last updated: February 07, 2013

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