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

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NCT02509026

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Study Location
Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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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. 
Key

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
Yes for different indication in trial country
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Official Title  ICMJE A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
Brief Summary The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spondylitis, Ankylosing
Intervention  ICMJE Biological: Etanercept
50 mg subcutaneous, once weekly, 24 weeks
Study Arms  ICMJE Experimental: Etanercept
etanercept 50 mg QW
Intervention: Biological: Etanercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 17, 2018)		210
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2015)		200
Actual Study Completion Date  ICMJE September 6, 2019
Actual Primary Completion Date May 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Colombia,   Czechia,   Finland,   France,   Germany,   Hungary,   Netherlands,   Poland,   Spain,   Sweden,   Taiwan,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02509026
Other Study ID Numbers  ICMJE B1801381
2015-000541-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP