Clinical trial NCT01521884: Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
Official title: Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients seen in a rheumatology practice

Brief 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.

Detailed description: Observational prospective study Purely descriptive

Eligibility 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

Primary outcomes:
measure: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
timeFrame: Baseline
measure: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
timeFrame: Month 6
measure: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
timeFrame: Month 12
measure: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
timeFrame: Month 18
measure: Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
timeFrame: Month 24
Secondary outcomes:
measure: Visual Analog Scale (VAS) Fatigue Score
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Health Assessment Questionnaire (HAQ) Total Score
timeFrame: Baseline, Month 6, 12, 18, 24
Other outcomes:
measure: Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)
timeFrame: Baseline, Month 6,1 2, 18, 24
measure: Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score
timeFrame: Baseline, Month 6, 12, 18, 24
measure: Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score
timeFrame: Baseline, Month 6, 12, 18, 24
Locations:
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: