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

February 16, 2011
April 16, 2013
May 2011
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01298531 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Axial Spondyloarthritis
  • Drug: etanercept
    etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
    Other Name: Enbrel
  • 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.
  • Active Comparator: etanercept
    Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
    Intervention: Drug: etanercept
  • 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.
    Interventions:
    • Drug: etanercept
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2013
January 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01298531
B1801132, 0881A1-4749
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP