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Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA (RE-EMBARK)

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ClinicalTrials.gov Identifier: NCT02509026
Recruitment Status : Active, not recruiting
First Posted : July 27, 2015
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Spondylitis, Ankylosing Biological: Etanercept Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
Actual Study Start Date : September 24, 2015
Estimated Primary Completion Date : July 18, 2019
Estimated Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Arm Intervention/treatment
Experimental: Etanercept
etanercept 50 mg QW
Biological: Etanercept
50 mg subcutaneous, once weekly, 24 weeks




Primary Outcome Measures :
  1. Estimate the proportion of subjects who flare [ Time Frame: At any time up to 40 weeks following withdrawal of etanercept ]
    Estimate the proportion of subjects who flare within 40 weeks following withdrawal of etanercept


Secondary Outcome Measures :
  1. Measurement of the time to flare following withdrawal of etanercept [ Time Frame: At any time up to 40 weeks following withdrawal of etanercept ]
    The time to flare following withdrawal of etanercept.

  2. Occurrence of Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS CRP) <1.3 [ Time Frame: witin 40 weeks following withdrawal ]
    Occurrence of ASDAS CRP <1.3 within 40 weeks following withdrawal of etanercept

  3. Occurrence of Assessment of Spondyloarthritis Society (ASAS) 20 [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of ASAS 20 within 40 weeks following withdrawal of etanercept

  4. Occurence of Assessment of Spondyloarthritis Society (ASAS) 40 [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of ASAS 40 within 40 weeks following withdrawal of etanercept

  5. Occurence of Assessment of Spondyloarthritis Society (ASAS) partial remission [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of ASAS partial remission within 40 weeks following withdrawal of etanercept

  6. Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: within 40 weeks following withdrawal ]
    ASDAS calculation within 40 weeks following withdrawal of etanercept

  7. Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of ASDAS major improvement within 40 weeks following withdrawal of etanercept

  8. Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of ASDAS clinically important improvement within 40 weeks following withdrawal of etanercept

  9. Nocturnal Back Pain Visual Analog Scale (VAS) [ Time Frame: within 40 weeks following withdrawal ]
    Nocturnal back pain will be measured within 40 weeks following withdrawal

  10. Total Back Pain Visual Analog Scale (VAS) [ Time Frame: within 40 weeks following withdrawal ]
    Total back pain will be measured within 40 weeks following withdrawal

  11. Bath Ankylosing Functional Index (BASFI) [ Time Frame: within 40 weeks following withdrawal ]
    BASFI and its components will be measured within 40 weeks following withdrawal of etanercept

  12. BathAnkylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: within 40 weeks following withdrawal ]
    BASDAI and its components will be measured within 40 weeks following withdrawal of etanercept

  13. Bath Ankylosing Disease Activity Index (BASDAI) 50 [ Time Frame: within 40 weeks following withdrawal ]
    Occurrence of BASDAI 50 will be calculated within 40 weeks following withdrawal of etanercept

  14. Measurement of High Sensitivity C-Reactive Protein (hsCRP) Laboratory Value [ Time Frame: within 40 weeks following withdrawal ]
    Measurement of hsCRP will be calculated within 40 weeks following withdrawal of etanercept

  15. EuroQoL-5D Health Questionnaire (EQ-5D) [ Time Frame: within 40 weeks following withdrawal ]
    EQ-5D will be measured within 40 weeks following withdrawal of etanercept

  16. Short Form 36 (SF-36) Questionnaire [ Time Frame: within 40 weeks following withdrawal ]
    SF-36 will be measured within 40 weeks following withdrawal of etanercept

  17. Work Productivity and Activity Impairment (WPAI) Questionnaire [ Time Frame: within 40 weeks following withdrawal ]
    WPAI will be measured within 40 weeks following withdrawal of etanercept

  18. Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) [ Time Frame: within 40 weeks following withdrawal ]
    MRI SIJ will be measured by SPARCC criteria within 40 weeks following withdrawal of etanercept

  19. Magnetic Resonance Imaging (MRI) spine [ Time Frame: within 40 weeks following withdrawal ]
    MRI spine will be measured by SPARCC criteria within 40 weeks following withdrawal of etanercept

  20. Measurement of the time to Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: following 12 weeks of retreatment ]
    The time to ASDAS inactive disease will be estimated over 12 weeks following retreatment in subjects who flare.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509026


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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02509026     History of Changes
Other Study ID Numbers: B1801381
2015-000541-24 ( EudraCT Number )
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Keywords provided by Pfizer:
non-radiographic axial spondyloarthritis

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors