Health Condition 1: null- Spondylitis, Ankylosing
Conditions
Interventions
Intervention1: Active Comparator: etanercept
In Period 1 : Subjects will receive via a prefilled syringe an active dose equivalent to 1.0ml of Etanercept solution once weekly SC once weekly. Addition
Sponsors
Pfizer Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosis of axial spondyloarthritis as defined by Assessments in Ankylosing Spondylitis (ASAS)criteria 2.Active symptoms defined as Ankylosing Spondylitis Disease Activity Index{BASDAI) greater than or equal to 4 3.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
Exclusion criteria: 1.Evidence of current or recent episode of uveitis 2.Evidence of IBD flare within 6 months 3.Previous treatment with an anti Tumor necrosis factor(TNF) 4.Active tuberculosis 5.Radiographic sacroiliitis grade 3-4 unilaterally or greater than or equal to 2 bilaterally
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12Timepoint: The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in Assessments in Ankylosing Spondylitis (ASDAS )at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in spinal mobility as measured by Bath Ankylosing Spondylitis Metrology Index{BASMI} (and its individual components), and occiput-to-wall distance, and chest expansion at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in tender and swollen joint counts (44 count) at 12 weeks and over time.Timepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in the acute phase reactants C Reactive Protein (CRP) and Erythrocyte sedimentation rate (ESR)at 12 weeks and over time.Timepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in the Bath Ankylosing Spondylitis Disease Activity Index(BASDAI )and its components at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) and its components at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in the Visual Analogue Scale(VAS )Physician Global Assessmentat 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in VAS nocturnal and total back pain over time at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline in Visual Analogue Scale(VAS) Subject Global Assessments at 12 weeks and over timeTimepoint: [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ];Changes from baseline on dactylitis and enthesitis score (MASES)at 12 weeks and over time.Timepoint: [ Time Frame: Baseline and 12 we | — |
Countries
Argentina, Belgium, Colombia, Czech Republic, Finland, France, Germany, Hungary, India, Mexico, Netherlands, Republic of Korea, Russian Federation, Spain, Taiwan, Turkey, United Kingdom
Contacts
Public ContactSwapnali Raut
Representing Pfizer Limited
Outcome results
None listed