Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18-49 years
Phase:
PHASE3
Brief 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 Physic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01258738
Start Date
February 1 2011
End Date
October 1 2014
Last Update
October 19 2015
Active Locations (50)
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1
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
2
Consultorios Reumatológicos Pampa
Buenos Aires, Argentina, C1428DZF
3
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
4
Reuma Instituut
Hasselt, Belgium, 3500