A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Axial Spondyloarthritis
Intervention: etanercept (Drug); etanercept (Drug); placebo (Drug)
Phase: Phase 4
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
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: Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.
Change From Baseline in BASDAI at Week 8
Change From Baseline in BASDAI Score at Weeks 12 and 16.
Number of Participants Using NSAIDs at Week 8.
Change From Baseline in Mini BASDAI at Week 8 (AUC).
Number of Participants Achieved BASDAI 50 at Week 8.
Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.
Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16
Number of Participants Achieving ASAS 20 at Week 8
Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.
Number of Participants Achieving ASAS 40 at Week 8
Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.
Number of Participants Achieving ASAS 70 at Week 8
Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.
Change From Baseline in ASDAS CRP Score at Week 8.
Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.
Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.
Change From Baseline in ASDAS ESR Score at Week 8.
Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.
Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)
Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)
Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
Institut Calot - Fondation Hopale, Berck-sur-Mer 62608, France
Hopital Pellegrin, Bordeaux Cedex 33076, France
Centre Hospitalier, Service de Rhumatologie, Cahors 46000, France
CHU Hopital Gabriel Montpied, Clermont-Ferrand 63003, France
Centre Hospitalier Sud Francilien, Corbeil Essonnes 91100, France
Hopital Bicetre, LE KREMLIN-BICETRE Cedex 94275, France
CH Le Mans, Le Mans 72037, France
Chu Dupuytren, Rhumatologie et Therapeutique, Limoges 87042, France
CHU Lapeyronie, Immuno-Rhumatologie, Montpellier 34000, France
Hopital de l'Archet, Nice 06202, France
Hopital Porte Madeleine, Orleans Cedex 1 45032, France
Hopital Bichat, Paris 75018, France
Hopital Cochin, Paris 75014, France
Hopital Saint Joseph - Service de Rhumatologie, Paris 75014, France
H�al Saint-Antoine, Paris 75012, France
Service de Rhumatologie, Paris 75651 Cedex 13, France
CHU Bois Guillaume - Service de Rhumatologie, Rouen 76031, France
CHU de Saint Etienne, Hopital Nord, Saint Etienne Cedex 2 42055, France
Hopital Purpan, Toulouse Cedex 09 31059, France
To obtain contact information for a study center near you, click here.
Starting date: May 2011
Last updated: July 28, 2014