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NCT01438892 Clinical Trial

Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Rheumatoid Arthritis Clinical Trial

Official title:
Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01438892
Other study ID # A3921144
Secondary ID
Status Completed
Phase N/A
First received September 20, 2011
Last updated April 4, 2013
Start date February 2012
Est. completion date January 2013

Study information
Verified date April 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

Description:

Cohort observational

Recruitment information / eligibility
Status Completed
Enrollment 396
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• tDMARDs
Traditional DMARDs for RA
• biodmards
Biologic DMARDs

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary HAQ 12 months No
Primary 36-Item Short-Form Health Survey (SF-36) 12 months No
Secondary Compliance 12 months No
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