Impact Of RA Therapy Compliance On Patient-Reported Outcomes

NCT01438892

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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

- Adults with moderate to severe RA who are currently using a DMARD

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


- Psoriatic Arthritis (PsA), Psoriasis (PsO), SSystemic Lupus Erythematosus (SLE),
Non-Disease modifying anti-rheumatic disease (non-DMARD) use

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Advanced Information
Descriptive Information
Brief Title Impact Of RA Therapy Compliance On Patient-Reported Outcomes
Official Title Impact Of RA Therapy Compliance On Patient-Reported Outcomes
Brief Summary Several observational studies have evaluated the comparative treatment costs associated with each agent, particularly those within the anti-TNF class, but few have evaluated the impact of therapy compliance, persistence, treatment patterns on patient reported outcomes, healthcare utilization and costs, using a provider database. This study is designed to fill in this information gap.
Detailed Description Cohort observational
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with modertate to severe Rheumatoid Arthritis
Condition Rheumatoid Arthritis
Intervention
  • Drug: tDMARDs
    Traditional DMARDs for RA
  • Drug: biodmards
    Biologic DMARDs
Study Groups/Cohorts
  • tDMARDs Group
    traditional DMARDs
    Intervention: Drug: tDMARDs
  • Biologics group
    Biologics used in RA
    Intervention: Drug: biodmards
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: April 4, 2013)
396
Original Estimated Enrollment
 (submitted: September 20, 2011)
600
Actual Study Completion Date January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults with moderate to severe RA who are currently using a DMARD

Exclusion Criteria:

  • Psoriatic Arthritis (PsA), Psoriasis (PsO), SSystemic Lupus Erythematosus (SLE), Non-Disease modifying anti-rheumatic disease (non-DMARD) use
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 United States
 
Administrative Information
NCT Number NCT01438892
Other Study ID Numbers A3921144
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 April 2013