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Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

Last updated on April 4, 2020

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- adult

- rheumatoid arthritis

- group 1: initiating etanercept as first biologic therapy

- group 2: DAS28

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- diagnosis of other inflammatory arthritis

NCT01646385
Pfizer
Completed
Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

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Descriptive Information
Brief Title Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry
Official Title Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data
Brief Summary This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.
Detailed Description patients recruited sequentially as seen in clinical practice
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population adult patients with a diagnosis of rheumatoid arthritis
Condition Rheumatoid Arthritis
Intervention
  • Drug: etanercept
    use as per routine clinical practice
  • Drug: non-biologic anti-rheumatic drugs
    use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)
Study Groups/Cohorts
  • etanercept
    adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy
    Intervention: Drug: etanercept
  • nbDMARD
    biologic-naive adult rheumatoid arthritis patients with DAS28 >4.2 treated with non-biologic anti-rheumatic drugs(s).
    Intervention: Drug: non-biologic anti-rheumatic drugs
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 Completed
Actual Enrollment
 (submitted: July 7, 2014)
6393
Original Actual Enrollment
 (submitted: July 19, 2012)
8227
Actual Study Completion Date August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • adult
  • rheumatoid arthritis
  • group 1: initiating etanercept as first biologic therapy
  • group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs

Exclusion Criteria:

  • diagnosis of other inflammatory arthritis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01646385
Other Study ID Numbers B1801348
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2014

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