Last updated date
ABOUT THIS STUDY
The purpose of this study is to investigate the efficacy and the safety of etanercept following withdrawal of etanercept in patients who have achieved a significant clinical response during the first period of the study.
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
Females and Males
- 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.
- 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.
A placebo is not used in this trial
Follow up: Estimated 28 days
Screening: Estimated 28 weeks
Treatment: Up to 64 weeks
Follow up: visits
Screening: Estimated 3 visits
Treatment: Up to 12 visits
Yes for different indication in trial country
Post-Trial Access to Study Drug
Keeping a diary
Vital signs and measurements
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