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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Institut Calot - Fondation Hopale
Berck-sur-Mer, , 62608 France
Contact
1-800-718-1021
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 TNF?
inhibitors or biologic agents.

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

NCT01298531
Pfizer
Completed
A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis

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Similar Trials

A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Axial Spondyloarthritis
  • 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.
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2013
January 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01298531
B1801132
0881A1-4749
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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