Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

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NCT01557322

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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

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Advanced Information
Descriptive Information
Brief Title Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
Official Title Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
Brief Summary
  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).
Detailed Description Retrospective database analysis
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 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.
Condition Rheumatoid Arthritis
Intervention
  • 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
Study Groups/Cohorts
  • Biologic
    Intervention: Biological: etanercept
  • non-biologic DMARD
    Intervention: Drug: methotrexate (MTX)
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: December 19, 2012)		1754
Original Estimated Enrollment
 (submitted: March 15, 2012)		1000
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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 NCT01557322
Other Study ID Numbers B1801345
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 CenterPfizer
PRS Account Pfizer
Verification Date August 2013