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Impact Of RA Therapy Compliance On Patient-Reported Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438892
First Posted: September 22, 2011
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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 Intervention
Rheumatoid Arthritis Drug: tDMARDs Drug: biodmards

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact Of RA Therapy Compliance On Patient-Reported Outcomes

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • Compliance [ Time Frame: 12 months ]

Enrollment: 396
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
tDMARDs Group
traditional DMARDs
Drug: tDMARDs
Traditional DMARDs for RA
Biologics group
Biologics used in RA
Drug: biodmards
Biologic DMARDs

Detailed Description:
Cohort observational
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01438892     History of Changes
Other Study ID Numbers: A3921144
First Submitted: September 20, 2011
First Posted: September 22, 2011
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