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Etanercept Withdrawal And Retreatment Study In Subjects With Non- Radiographic Axial Spondyloarthritis (Chronic Lower Back Pain)

Last updated on August 1, 2019

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Study Location
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514 United States
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.
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  • Male or female 18 to 49 years of age.
    • Diagnosis of axial SpA duration of symptoms more than 3 months and less than 5 years back pain with a less than favorable response to NSAIDs.
    • Back pain with a less than favorable response to current intake of an NSAID.
  • Ability to self-inject investigational product or have a designee who can do so. 
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
  • Any previous treatment with a tumor necrosis factor-alpha inhibitor, B/T cell inhibitor or other biologic or immunosuppressive agent for a condition other than IBD.
    • Known or suspected allergy, hypersensitivity, or contraindication to etanercept.
  • Pregnant or breastfeeding; male participants with partners currently pregnant; fertile participants unwilling to use highly effective methods of contraception for the duration of the study and for 28 days after the last dose of the investigational study drug.
Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 28 days
Screening: Estimated 28 weeks
Treatment: Up to 64 weeks
Site Visits
Follow up: visits
Screening: Estimated 3 visits
Treatment: Up to 12 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Keeping a diary
Mri
Physical examination
Questionnaire
Urine test
Vital signs and measurements
X-rays
NCT02509026
Pfizer
Active, not recruiting
Etanercept Withdrawal And Retreatment Study In Subjects With Non- Radiographic Axial Spondyloarthritis (Chronic Lower Back Pain)

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Pfizer Clinical Trials Contact Center

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[email protected]

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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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