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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NCT01258738

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Study Location
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman, T4000AXL, Argentina
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Spondylitis, Ankylosing
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

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Spondylitis, AnkylosingStudy 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
NCT01258738
  1. San Miguel de Tucuman, Tucuman
  2. Buenos Aires,
  3. Gent,
  4. Hasselt,
  5. Kortrijk,
  6. Chia, Cundinamarca
  7. Bucaramanga, Santander
  8. Bucaramanga, Santander
  9. Praha 11 - Chodov,
  10. Praha 2,
  11. Uherske Hradiste,
  12. Helsinki,
  13. Hyvinkää,
  14. LE KREMLIN-BICETRE Cedex,
  15. Montpellier,
  16. Paris,
  17. Tours Cedex 9,
  18. Berlin,
  19. Erlangen,
  20. Hamburg,
  21. Herne,
  22. Vogelsang-Gommern,
  23. Budapest,
  24. Budapest,
  25. Budapest,
  26. Budapest,
  27. Debrecen,
  28. Veszprem,
  29. Incheon, Gwangyeogsiv
  30. Gwangju,
  31. Seoul,
  32. Amsterdam, North-Holland
  33. Leiden,
  34. Moscow,
  35. Moscow,
  36. Saint-Petersburg,
  37. Saint-Petersburg,
  38. Saint-Petersburg,
  39. Sevilla, Andalucia
  40. Alcorcon, Madrid
  41. Cordoba,
  42. La Coruña,
  43. Kaohsiung,
  44. Taichung,
  45. Taipei,
  46. Cambridge, Cambridgeshire
  47. Basingstoke, Hants.
  48. Norwich, Norfolk
  49. Dudley, West Midlands
  50. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Spondylitis, Ankylosing
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2015)		225
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2010)		200
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Colombia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01258738
Other Study ID Numbers  ICMJE B1801031
0881A3-4725 ( Other Identifier: Alias Study Number )
2010-020077-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP