Clinical trial NCT01298531: A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Axial Spondyloarthritis
Keywords: Etanercept
Axial Spondyloarthritis
NSAIDs sparing effect
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Non Steroidal Anti Inflammatory Drug (NSAID) Assessment of the SpondyloArthritis International Society (ASAS) Score at Week 8.
timeFrame: Week 8
Secondary outcomes:
measure: Total NSAID ASAS [Area Under Curve (AUC)] Score From Baseline to Week 8.
timeFrame: Week 8
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4.
timeFrame: Week 4
measure: Change From Baseline in BASDAI at Week 8
timeFrame: Week 8
measure: Change From Baseline in BASDAI Score at Weeks 12 and 16.
timeFrame: Week 12 and 16
measure: Number of Participants Using NSAIDs at Week 8.
timeFrame: Week 8
measure: Change From Baseline in Mini BASDAI at Week 8 (AUC).
timeFrame: Week 8
measure: Number of Participants Achieved BASDAI 50 at Week 8.
timeFrame: Week 8
measure: Number of Participants Achieved BASDAI 50 at Weeks 4, 12 and 16.
timeFrame: Weeks 4, 12 and 16
measure: Number of Participants Achieving ASAS 20 (Assessment of the Spondylo Arthritis International Society 20) at Weeks 4, 12 and 16
timeFrame: Weeks 4, 12 and 16
measure: Number of Participants Achieving ASAS 20 at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving ASAS 40 at Weeks 4, 12 and 16.
timeFrame: Weeks 4, 12 and 16
measure: Number of Participants Achieving ASAS 40 at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving ASAS 70 at Weeks 4, 12 and 16.
timeFrame: Weeks 4, 12 and 16
measure: Number of Participants Achieving ASAS 70 at Week 8
timeFrame: Week 8
measure: Change From Baseline in ASDAS CRP (Ankylosing Spondylitis Disease Activity Score-C Reactive Protein) Score at Week 4.
timeFrame: Week 4
measure: Change From Baseline in ASDAS CRP Score at Week 8.
timeFrame: Week 8
measure: Change From Baseline in ASDAS CRP Score at Weeks 12 and 16.
timeFrame: Weeks 12 and 16
measure: Change From Baseline in ASDAS ESR (Ankylosing Spondylitis Disease Activity Score-Erythrocyte Sedimentation Rate) Score at Week 4.
timeFrame: Week 4
measure: Change From Baseline in ASDAS ESR Score at Week 8.
timeFrame: Week 8
measure: Change From Baseline in ASDAS ESR Score at Weeks 12 and 16.
timeFrame: Weeks 12 and 16
measure: Change in NSAID ASAS Score From Baseline to Week 16 (ETN Arm Only)
timeFrame: Week 16
measure: Change in NSAID ASAS Score From Week 8 to Week 16 (Placebo Only)
timeFrame: Week 16
measure: Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 8
timeFrame: Week 8
Other outcomes:
measure: Change From Baseline in BAS-G (Bath Ankylosing Spondylitis-Global) Score at Week 4
timeFrame: Week 4
measure: Change From Baseline in BAS-G Score at Week 8
timeFrame: Week 8
measure: Change From Baseline in BAS-G Score at Weeks 12 and 16.
timeFrame: Weeks 12 and 16
measure: Change From Baseline in Total Back Pain at Week 4
timeFrame: Week 4
measure: Change From Baseline in Total Back Pain at Week 8
timeFrame: Week 8
measure: Change From Baseline in Total Back Pain at Weeks 4, 8, 12 and 16
timeFrame: Weeks 4, 8, 12 and 16
measure: Change From Baseline in Nocturnal Back Pain at Week 4
timeFrame: Week 4
measure: Change From Baseline in Nocturnal Back Pain at Week 8
timeFrame: Week 8
measure: Change From Baseline in Nocturnal Back Pain at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in BASFI (Bath Ankylosing Spondylitis Functional Index ) at Week 4
timeFrame: Week 4
measure: Change From Baseline in BASFI at Week 8
timeFrame: Week 8
measure: Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Week 4
timeFrame: Week 4
measure: Change From Baseline in BASDAI Level of Morning Stiffness-related Scores at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in PGA (Physician Global Assessment) at Week 4
timeFrame: Week 4
measure: Change From Baseline in PGA (Physician Global Assessment) at Week 8
timeFrame: Week 8
measure: Change From Baseline in PGA at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in Each BASFI Component at Week 4
timeFrame: Week 4
measure: Change From Baseline in Each BASFI Component at Week 8
timeFrame: Week 8
measure: Change From Baseline in Each BASFI Component at Week 12
timeFrame: Week 12
measure: Change From Baseline in Each BASFI Component at Week 16
timeFrame: Week 16
measure: Change From Baseline in Swollen Joint Counts at Weeks 4, 8, 12 and 16
timeFrame: Weeks 4, 8, 12 and 16
measure: Change From Baseline in Tenderness Joint Counts at Weeks 4, 8, 12 and 16
timeFrame: Weeks 4, 8, 12 and 16
measure: Change From Baseline in MASES (Maastricht Ankylosing Spondylitis Entheses Score) Score at Weeks 4, 8, 12 and 16
timeFrame: Weeks 4, 8, 12 and 16
measure: Number of Participants With Minimum Clinically Important Improvement (MCII) at Week 8
timeFrame: Week 8
measure: Number of Participants With MCII at Weeks 4, 12 and 16
timeFrame: Weeks 4, 12 and 16
measure: Number of Participants With Minimum Clinically Important Deterioration (MCID) at Weeks 4, 8, 12 and 16
timeFrame: Weeks 4, 8, 12 and 16
measure: Number of Participants With Patient Acceptable Symptom State (PASS) at Week 8
timeFrame: Week 8
measure: Number of Participants With PASS at Weeks 4, 12 and 16
timeFrame: Weeks 4, 12 and 16
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4
timeFrame: Week 4
measure: Change From Baseline in BASMI at Week 8
timeFrame: Week 8
measure: Change From Baseline in BASMI at Weeks 12 and 16
timeFrame: Weeks 12 and 16
measure: Change From Baseline in BASMI Components at Week 4
timeFrame: Week 4
measure: Change From Baseline in BASMI Components at Week 8
timeFrame: Week 8
measure: Change From Baseline in BASMI Components at Week 12
timeFrame: Week 12
measure: Change From Baseline in BASMI Components at Week 16
timeFrame: Week 16
measure: Change From Baseline in Chest Expansion at Week 4
timeFrame: Week 4
measure: Change From Baseline in Chest Expansion at Week 8
timeFrame: Week 8
measure: Change From Baseline in Chest Expansion at Weeks 12 and 16
timeFrame: Weeks 12 and 16
Locations:
city: Berck-sur-Mer
country: France
facility: Institut Calot - Fondation Hopale
city: Bordeaux Cedex
country: France
facility: Hopital Pellegrin
city: Cahors
country: France
facility: Centre Hospitalier, Service de Rhumatologie
city: Clermont-Ferrand
country: France
facility: CHU Hopital Gabriel Montpied
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: LE KREMLIN-BICETRE Cedex
country: France
facility: Hopital Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Limoges
country: France
facility: Chu Dupuytren, Rhumatologie et Therapeutique
city: Montpellier
country: France
facility: CHU Lapeyronie, Immuno-Rhumatologie
city: Nice
country: France
facility: Hopital de l'Archet
city: Orleans Cedex 1
country: France
facility: Hopital Porte Madeleine
city: Paris
country: France
facility: H�al Saint-Antoine
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Saint Joseph - Service de Rhumatologie
city: Paris
country: France
facility: Hopital Bichat
city: Paris
country: France
facility: Service de Rhumatologie
city: Rouen
country: France
facility: CHU Bois Guillaume - Service de Rhumatologie
city: Saint Etienne Cedex 2
country: France
facility: CHU de Saint Etienne, Hopital Nord
city: Toulouse Cedex 09
country: France
facility: Hopital Purpan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Dougados M, Wood E, Gossec L, Dubanchet A, Logeart I, van der Heijde D. Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis. J Rheumatol. 2015 Dec;42(12):2361-8. doi: 10.3899/jrheum.150378. Epub 2015 Nov 15.
citation: Dougados M, Wood E, Combe B, Schaeverbeke T, Miceli-Richard C, Berenbaum F, Koppiker N, Dubanchet A, Logeart I. Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study. Arthritis Res Ther. 2014 Nov 27;16(6):481. doi: 10.1186/s13075-014-0481-5.