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Impact Of RA Therapy Compliance On Patient-Reported Outcomes

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ClinicalTrials.gov Identifier: NCT01438892
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: tDMARDs Drug: biodmards

Detailed Description:
Cohort observational

Study Type : Observational
Actual Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact Of RA Therapy Compliance On Patient-Reported Outcomes
Study Start Date : February 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
U.S. FDA Resources

Group/Cohort Intervention/treatment
tDMARDs Group
traditional DMARDs
Drug: tDMARDs
Traditional DMARDs for RA
Biologics group
Biologics used in RA
Drug: biodmards
Biologic DMARDs



Primary Outcome Measures :
  1. HAQ [ Time Frame: 12 months ]
  2. 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with modertate to severe Rheumatoid Arthritis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438892


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01438892     History of Changes
Other Study ID Numbers: A3921144
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Pfizer:
rheumatoid arthritis
therapy compliance

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases