Overview

This trial is active, not recruiting.

Condition spondylitis, ankylosing
Treatments etanercept, background nsaid, placebo
Phase phase 3
Sponsor Pfizer
Start date February 2011
End date November 2012
Trial size 200 participants
Trial identifier NCT01258738, 0881A3-4725, B1801031

Summary

This is a two part study. During period one there will be a comparsion 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
etanercept ENBREL
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.
background nsaid
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.
(Placebo Comparator)
In Period 1: Subjects will receive in a prefilled syringe with a PLACEBO dose equivalent to 1.0 ml of placebo solution once weekly SC Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
placebo
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.
background nsaid
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).

Primary Outcomes

Measure
The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12.
time frame: 12 weeks

Secondary Outcomes

Measure
Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 40 at time points other than 12 weeks and over time
time frame: 12 weeks
Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 20 at 12 weeks and over time
time frame: 12 weeks
Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 5/6 at 12 weeks and over time
time frame: 12 weeks
Changes from baseline in Assessments in Ankylosing Spondylitis (ASDAS )at 12 weeks and over time
time frame: Baseline and 12 weeks
Proportion of subjects with Assessments in Ankylosing Spondylitis (ASAS) partial remission at 12 weeks and over time
time frame: 12 weeks
Time to: Assessments in Ankylosing Spondylitis( ASAS) partial remission at 12 weeks and over time
time frame: 12 weeks
Changes from baseline in Visual Analogue Scale(VAS) Subject Global Assessments at 12 weeks and over time
time frame: Baseline and 12 weeks
Changes from baseline in the Visual Analogue Scale(VAS )Physician Global Assessmentat 12 weeks and over time
time frame: Baseline and 12 weeks
Changes from baseline in VAS nocturnal and total back pain over time at 12 weeks and over time
time frame: Baseline and 12 weeks
Changes from baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) and it's components at 12 weeks and over time
time frame: Baseline and 12 weeks
Changes from baseline in the Bath Ankylosing Spondylitis Disease Activity Index(BASDAI )and it's components at 12 weeks and over time
time frame: Baseline and 12 weeks
Proportion of subjects who achieved Bath Ankylosing Spondylitis Disease Activity Index (BASDAI )20 and BASDAI 50 at 12 weeks and over time
time frame: 12 weeks
Changes in Bath Ankylosing Spondylitis Global Index (BAS - G) BAS-G at 12 weeks and over time
time frame: 12 weeks
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 time
time frame: Baseline and 12 weeks
Changes in inflammation at week 12 as measured by Magnetic resonance imaging (MRI )of the spine at 12 weeks and over time
time frame: 12 weeks
Changes from baseline in tender and swollen joint counts (44 count) at 12 weeks and over time.
time frame: Baseline and 12 weeks
Changes from baseline on dactylitis and enthesitis score (MASES)at 12 weeks and over time.
time frame: Baseline and 12 weeks
Changes from baseline in the acute phase reactants C Reactive Protein (CRP) and Erythrocyte sedimentation rate (ESR)at 12 weeks and over time.
time frame: Baseline and 12 weeks
Safety will be assessed throughout the study including but not limited to adverse events, and serious adverse events during the study at 12 weeks and over time.
time frame: 12 weeks
Health Outcome Assessment • EQ D-5: The EuroQol EQ 5D Health State Profile at 12 weeks and over 104 weeks.
time frame: 12 weeks
Health Outcome Assessment •Short Form -36 Health Survey (SF36) at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment • Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Healthoutcomes Assessment: Ankylosing Spondylitis Quality of Life (ASQoL) at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Healthoutcomes Assessment: Ankylosing Spondylitis Work Instability Index (AS WIS)at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment Work Productivity and Activity Impairment (WPAI)at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment Multidimensional Fatigue Inventory (MFI) at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment : Medical Outcomes Study (MOS) Sleep Scale at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment :The Minimum Clinically Important Improvement (MCII) at 12 weeks and over time 104 weeks.
time frame: 12 weeks
Health Outcome Assessment : Patient Acceptable Symptom State (PASS)at 12 weeks and over time 104 weeks.
time frame: 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 49 years old.

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

Additional Information

Official title A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study of Etanercept on a Background Non Steroidal Anti-Inflammatory Drug in the Treatment of Adult Subjects With Non Radiographic Axial Spondyloarthritis With a 92 Week Open Label Extension
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Pfizer.