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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 (AS EARLY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01258738
First received: December 9, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Spondylitis, Ankylosing
Biological: etanercept
Drug: Background NSAID
Other: PLACEBO
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects who achieve Assessments in Ankylosing Spondylitis (ASAS) 40 at week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 20 at 12 weeks and over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve: Assessments in Ankylosing Spondylitis (ASAS) 5/6 at 12 weeks and over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in Assessments in Ankylosing Spondylitis (ASDAS )at 12 weeks and over time [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects with Assessments in Ankylosing Spondylitis (ASAS) partial remission at 12 weeks and over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Time to: Assessments in Ankylosing Spondylitis( ASAS) partial remission at 12 weeks and over time [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in Visual Analogue Scale(VAS) Subject Global Assessments at 12 weeks and over time [ 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 time [ 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 time [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in Bath Ankylosing Spondylitis Global Index (BAS - G) BAS-G at 12 weeks and over time [ Time Frame: 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 time [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes from baseline in tender and swollen joint counts (44 count) at 12 weeks and over time. [ 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. [ 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. [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Health Outcome Assessment • EQ D-5: The EuroQol EQ 5D Health State Profile at 12 weeks and over 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment •Short Form -36 Health Survey (SF36) at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment • Hospital Anxiety and Depression Scale (HADS) at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Healthoutcomes Assessment: Ankylosing Spondylitis Quality of Life (ASQoL) at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Healthoutcomes Assessment: Ankylosing Spondylitis Work Instability Index (AS WIS)at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment Work Productivity and Activity Impairment (WPAI)at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment Multidimensional Fatigue Inventory (MFI) at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment : Medical Outcomes Study (MOS) Sleep Scale at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment :The Minimum Clinically Important Improvement (MCII) at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Outcome Assessment : Patient Acceptable Symptom State (PASS)at 12 weeks and over time 104 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: October 2014
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
Biological: etanercept
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.
Other Name: ENBREL
Drug: 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: PLACEBO
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.
Other: 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.
Drug: 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).

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258738

  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01258738     History of Changes
Other Study ID Numbers: B1801031, 0881A3-4725
Study First Received: December 9, 2010
Last Updated: October 14, 2013
Health Authority: European Union: European Medicines Agency ,Argentina: Ministry of Health , Korea: Institutional R

Keywords provided by Pfizer:
Early ankylosing spondylitis (SpA) study; efficacy and safety and health out comes

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Arthritis
Bone Diseases
Bone Diseases, Infectious
Infection
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014