NCT01438892

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

September 20, 2011

Last Update Submit

April 4, 2013

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritistherapy compliance

Outcome Measures

Primary Outcomes (2)

  • HAQ

    12 months

  • 36-Item Short-Form Health Survey (SF-36)

    12 months

Secondary Outcomes (1)

  • Compliance

    12 months

Study Arms (2)

tDMARDs Group

traditional DMARDs

Drug: tDMARDs

Biologics group

Biologics used in RA

Drug: biodmards

Interventions

tDMARDsDRUG

Traditional DMARDs for RA

tDMARDs Group
biodmardsDRUG

Biologic DMARDs

Biologics group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with modertate to severe Rheumatoid Arthritis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidPatient Compliance

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 22, 2011

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04