Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment sc anti-tnf
Phase phase 4
Sponsor Pfizer
Start date November 2010
End date March 2014
Trial size 75 participants
Trial identifier NCT01521884, 0881A1-4748, B1801046

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
sc anti-tnf
SC anti-TNF

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
Relationship between the different components of AIMS2 and fatigue.
time frame: 2 years
Relationship between the different components of AIMS2 and disease activity scores (DAS28)
time frame: 2 years
Relationship between fatigue (VAS scale) and disease activity scores (DAS28)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Longitudinal Changes in Fatigue and Health Status (aims2) in RA Patients Treated With Sc Anti-tnf-alpha Therapy (FARA-study)
Description Observational prospective study Purely descriptive
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Pfizer.