Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01521884
First received: August 19, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.


Condition Intervention Phase
Rheumatoid Arthritis
Other: SC anti-TNF
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Longitudinal Changes in Fatigue and Health Status (aims2) in RA Patients Treated With Sc Anti-tnf-alpha Therapy (FARA-study)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Longitudinal changes in health status (AIMS2 components: Physical, Affect, Symptom, Social Interaction and Role), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Longitudinal changes in fatigue (VAS scale), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Longitudinal changes in health status (AIMS2 component Physical), over two years of follow up, in a cohort of RA patients treated with SC anti-TNF-α therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relationship between the different components of AIMS2 and fatigue. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relationship between the different components of AIMS2 and disease activity scores (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relationship between fatigue (VAS scale) and disease activity scores (DAS28) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RA Patients treated with SC anti-TNF Other: SC anti-TNF
SC anti-TNF

Detailed Description:

Observational prospective study Purely descriptive

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients seen in a rheumatology practice

Criteria

Inclusion Criteria:

Patients who:

  • Are active RA patients (as judged by treating MD)
  • Are 18 years of age or older at time of consent
  • Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

Exclusion Criteria:

Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.

Participation in other clinical or observational trials

  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: NCT01521884

Locations
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
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: NCT01521884     History of Changes
Other Study ID Numbers: 0881A1-4748, B1801046
Study First Received: August 19, 2011
Last Updated: February 14, 2014
Health Authority: Belgium: Institutional Review Board

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 September 14, 2014