Eligibility criteria
Condition
Ankylosing Spondylitis
Sex
Females and Males
Age
18-49 years
Inclusion criteria
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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
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- 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
Subcutaneous injections
Placebo
A placebo is not used in this trial
Duration
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