Impact Of RA Therapy Compliance On Patient-Reported Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01438892
First received: September 20, 2011
Last updated: April 4, 2013
Last verified: April 2013
  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 ] [ Designated as safety issue: No ]
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438892

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01438892     History of Changes
Other Study ID Numbers: A3921144
Study First Received: September 20, 2011
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014