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
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 April 17, 2014