Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: biodmards; Drug: tDMARDs

• Registration Number: NCT01438892
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-22
• Study Start: 2012-02
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biologics group	biodmards	Biologics used in RA
tDMARDs Group	tDMARDs	traditional DMARDs

Primary Outcome Measures

Name	Time	Method
36-Item Short-Form Health Survey (SF-36)	12 months
HAQ	12 months

Secondary Outcome Measures

Name	Time	Method
Compliance	12 months