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Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

Last updated on November 6, 2019

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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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Descriptive Information
Brief TitleCharacterize Patients With Moderately Active Rheumatoid Arthritis (RA)
Official TitleEvaluation 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 DescriptionRetrospective database analysis
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationThe 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.
ConditionRheumatoid 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 StatusCompleted
Actual Enrollment
 (submitted: December 19, 2012)
1754
Original Estimated Enrollment
 (submitted: March 15, 2012)
1000
Actual Study Completion DateSeptember 2012
Actual Primary Completion DateSeptember 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01557322
Other Study ID NumbersB1801345
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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