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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 December 6, 2018

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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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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
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
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.
patients recruited sequentially as seen in clinical practice
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
adult patients with a diagnosis of rheumatoid arthritis
Rheumatoid Arthritis
  • 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)
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6393
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01646385
B1801348
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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