A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

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NCT01298531

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Study Location
Institut Calot - Fondation Hopale
Berck-sur-Mer, , 62608, France
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Axial Spondyloarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects aged 18 years and over at the time of consent to the study.

- Diagnosis of SpA, as defined by the ASAS criteria for axial SpA

- Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.

- Active axial involvement defined by mini BASDAI

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


- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.


- Subjects who have received any previous treatment with etanercept or other TNFα
inhibitors or biologic agents.


- Subjects with a known or expected allergy, contraindication, or hypersensitivity to
etanercept or its excipients.

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Axial SpondyloarthritisA Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
NCT01298531
  1. Berck-sur-Mer,
  2. Bordeaux Cedex,
  3. Cahors,
  4. Clermont-Ferrand,
  5. Corbeil Essonnes,
  6. LE KREMLIN-BICETRE Cedex,
  7. Le Mans,
  8. Limoges,
  9. Montpellier,
  10. Nice,
  11. Orleans Cedex 1,
  12. Paris,
  13. Paris,
  14. Paris,
  15. Paris,
  16. Paris,
  17. Rouen,
  18. Saint Etienne Cedex 2,
  19. Toulouse Cedex 09,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
Official Title  ICMJE A Multi Centre, Double Blind, Placebo-controlled Study to Evaluate the Non Steroidal Anti-inflamatory Drugs (NSAIDS) Sparing Effect of Etanercept in Adult Subjects With Axial Involvement of Spondyloarthritis
Brief Summary This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Axial Spondyloarthritis
Intervention  ICMJE
  • Drug: etanercept
    etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
    Other Name: Enbrel
  • Drug: etanercept
    etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
    Other Name: Enbrel
  • Drug: placebo
    placebo subcutaneous (SC) injections once weekly for 8 weeks.
Study Arms  ICMJE
  • Active Comparator: etanercept
    Group A: etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
    Intervention: Drug: etanercept
  • Placebo Comparator: etanercept-placebo
    Group B: placebo subcutaneous (SC) injections once weekly for (how many) weeks follwed by etanercept 50 mg SC injections once weekly.
    Interventions:
    • Drug: etanercept
    • Drug: placebo
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: July 28, 2014)		90
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2011)		80
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects aged 18 years and over at the time of consent to the study.
  • Diagnosis of SpA, as defined by the ASAS criteria for axial SpA
  • Axial involvement refractory to previous or current intake of NSAIDs, defined as at least 2 NSAIDs at maximum tolerated dose determined from past medical history taken for a duration of > 1 month (for both NSAIDs combined) before the Screening visit.
  • Active axial involvement defined by mini BASDAI

Exclusion Criteria:

  • Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
  • Subjects who have received any previous treatment with etanercept or other TNF? inhibitors or biologic agents.
  • Subjects with a known or expected allergy, contraindication, or hypersensitivity to etanercept or its excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01298531
Other Study ID Numbers  ICMJE B1801132
0881A1-4749
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 July 2014

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