A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis (SPARSE)

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 16, 2011
Last updated: April 16, 2013
Last verified: April 2013

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.

Condition Intervention Phase
Axial Spondyloarthritis
Drug: etanercept
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The area under the curve (AUC) between randomization and Week 8 for the NSAID ASAS score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The efficacy of etanercept for symptom control compared with that of placebo at Weeks 4 and 8. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The change in concomitant NSAID treatment requirement between Baseline and Week 16 in the group originally receiving etanercept. [ Time Frame: 16weeks ] [ Designated as safety issue: No ]
  • The change in concomitant NSAID treatment requirement between Week 8 and Week 16 in the group originally receiving placebo [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The efficacy of etanercept in the group receiving etanercept from Baseline up to Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • The change in efficacy in the group originally receiving placebo group from Week 8 to Week 16 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The safety and tolerability of etanercept in this subject population [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etanercept
Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
Drug: etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
Other Name: Enbrel
Placebo Comparator: etanercept-placebo
Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
Drug: etanercept
etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
Other Name: Enbrel
Drug: placebo
placebo subcutaneous (SC) injections once weekly for 8 weeks.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01298531

Institut Calot - Fondation Hopale
Berck-sur-Mer, France, 62608
Hopital Pellegrin
Bordeaux Cedex, France, 33076
Centre Hospitalier, Service de Rhumatologie
Cahors, France, 46000
CHU Hopital Gabriel Montpied
Clermont-Ferrand, France, 63003
Centre Hospitalier Sud Francilien
Corbeil Essonnes, France, 91100
Hopital Bicetre
LE KREMLIN-BICETRE Cedex, France, 94275
CH Le Mans
Le Mans, France, 72037
Chu Dupuytren, Rhumatologie et Therapeutique
Limoges, France, 87042
CHU Lapeyronie, Immuno-Rhumatologie
Montpellier, France, 34000
Hopital de l'Archet
Nice, France, 06202
Hopital Porte Madeleine
Orleans Cedex 1, France, 45032
Hopital Saint Joseph - Service de Rhumatologie
Paris, France, 75014
H�al Saint-Antoine
Paris, France, 75012
Hopital Bichat
Paris, France, 75018
Hopital Cochin
Paris, France, 75014
Service de Rhumatologie
Paris, France, 75651 Cedex 13
CHU Bois Guillaume - Service de Rhumatologie
Rouen, France, 76031
CHU de Saint Etienne, Hopital Nord
Saint Etienne Cedex 2, France, 42055
Hopital Purpan
Toulouse Cedex 09, France, 31059
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01298531     History of Changes
Other Study ID Numbers: B1801132, 0881A1-4749
Study First Received: February 16, 2011
Last Updated: April 16, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Pfizer:
Axial Spondyloarthritis
NSAIDs sparing effect

Additional relevant MeSH terms:
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases
Bone Diseases, Infectious
Anti-Inflammatory Agents, Non-Steroidal
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
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 July 26, 2014