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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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman, T4000AXL Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01258738
Pfizer
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

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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
A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study Of Etanercept On A Background Nsaid In The Treatment Of Adult Subjects With Non Radiographic Axial Spondyloarthritis With A 92 Week Open Label Extension
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Spondylitis, Ankylosing
  • 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.
  • 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).
  • 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.
    Interventions:
    • Biological: etanercept
    • Drug: Background NSAID
  • 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.
    Interventions:
    • Other: PLACEBO
    • Drug: Background NSAID


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
October 2014
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Taiwan,   United Kingdom
 
 
NCT01258738
B1801031
0881A3-4725 ( Other Identifier: Alias Study Number )
2010-020077-16 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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