A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With 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

• 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.
• 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.

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 TNF? inhibitors or biologic agents.
• Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.