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

Last updated on July 4, 2018

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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.
Show details
  • 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.
Treatment: Up to 64 weeks
Screening: Estimated 28 weeks
Follow up: Estimated 28 days
Site Visits
Treatment: Up to 12 visits
Screening: Estimated 3 visits
Follow up: 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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Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
A Multicenter Open-label Study Of Etanercept Withdrawal And Retreatment In Subjects With Non-radiographic Axial Spondyloarthritis Who Achieved Adequate 24 Week Response
The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.
This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment.
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Treatment
Spondylitis, Ankylosing
Biological: Etanercept
50 mg subcutaneous, once weekly, 24 weeks
Experimental: Etanercept
etanercept 50 mg QW
Intervention: Biological: Etanercept
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 4, 2019
July 18, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a less than favorable response to NSAIDs

Exclusion Criteria:

  • radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   Colombia,   Czechia,   Finland,   France,   Germany,   Hungary,   Netherlands,   Poland,   Spain,   Sweden,   Taiwan,   United States
Czech Republic
 
NCT02509026
B1801381
2015-000541-24 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

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

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