Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: etanercept; Background NSAID; PLACEBO; Background NSAID
Intervention description: In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.; Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.; In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.; Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).
Intervention MeSH terms: Etanercept; Anti-Inflammatory Agents, Non-Steroidal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes

Summary:

      This is a two part study. During period one there will be a comparison of Etanercept (ETN)
      against a placebo with both arms maintaining the background anti inflammatory drug prescribed
      by their Physician. The hypothesis is that Etanercept will be superior to the placebo arm as
      determined by the proportion of subjects achieving Assessments in Ankylosing Spondylitis
      (ASAS)40 improvement at 12 weeks. This will be followed by 92 weeks extension where everyone
      in the trial receives Etanercept (ETN) and a background non steroidal anti inflammatory
      drug(NSAID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing
             Spondylitis (ASAS)criteria

          -  Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) > or
             = 4

          -  Axial symptoms of back pain with a less than favorable response to on steroidal anti
             inflammatory drugs at optimal dosage for greater than 4 weeks

        Exclusion Criteria:

          -  Evidence of current or recent episode of uveitis

          -  Evidence of IBD flare within 6 months

          -  Previous treatment with an anti Tumor necrosis factor(TNF)

          -  Active tuberculosis

          -  Radiographic sacroiliitis grade 3-4 unilaterally or >= 2 bilaterally