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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01298531
First received: February 16, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
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
Pfizer
Investigators
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:
Etanercept
Axial Spondyloarthritis
NSAIDs sparing effect

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Bone Diseases, Infectious
Infection
Anti-Inflammatory Agents, Non-Steroidal
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Analgesics
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