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Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

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

The Test Group will be patients with rheumatoid arthritis, newly starting therapy with
etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:

- Patients aged 18 years and over at the time of diagnosis;

- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);

- Patients who have given informed consent for long term follow-up and access to all
medical records;

- Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel)
for RA.

The Control Group:

- Patients aged 18 years and over a the time of diagnosis;

- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);

- Patients who have given informed consent for long term follow-up and access to all
medical records; Patients are receiving at least one traditional DMARD and have never
been prescribed a biologic agent;

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

Per BSRBR registry since data is retropsectively being analyzed

NCT01557322
Pfizer
Completed
Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

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Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
  1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
  2. To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).
Retrospective database analysis
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
The BSR Biologics Register tracks the progress of patients with severe rheumatoid arthritis and other rheumatic conditions who are taking biologic therapy and those who are biologic naive.
Rheumatoid Arthritis
  • Biological: etanercept
    This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
    Other Name: Enrel
  • Drug: methotrexate (MTX)
    This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
    Other Name: non-biologic DMARD
  • Biologic
    Intervention: Biological: etanercept
  • non-biologic DMARD
    Intervention: Drug: methotrexate (MTX)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1754
September 2012
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:

  • Patients aged 18 years and over at the time of diagnosis;
  • Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ?5.1);
  • Patients who have given informed consent for long term follow-up and access to all medical records;
  • Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.

The Control Group:

  • Patients aged 18 years and over a the time of diagnosis;
  • Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ?5.1);
  • Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent;

Exclusion Criteria:

Per BSRBR registry since data is retropsectively being analyzed

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
 
 
NCT01557322
B1801345
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

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