Arthritis, Rheumatoid Clinical Trial
Official title:
Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet
Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet.
Rheumatoid arthritis is characterised with a sudden onset , with pains in the little finger
or toe joints, progressively affecting various joints and symptomatic morning stiffness. For
subjects with RA, morning stiffness entails a quite essential restriction in the everyday
life and in the life quality. This observational, uncontrolled, multicentric study is aimed
to assess the improvement in the activity status or QoL of subjects with RA being treated
with the Tempus tablet. A total of 8,000 subjects with diagnosed, active RA will be included
in the study The study will apply to 2 target groups: general physicians, practicing doctors
and interns (in-house doctors) with an observation period of 3 months; and specialists
(rheumatologist) with an observation period of 9 months. Three subjects are expected per
in-house doctor and 10 subjects per rheumatologist.
OBJECTIVES
Primary Objective:
- To examine, to what extent the subject will be directly benefited with the decrease in
the morning arthritis symptom in the sense of an improvement in the life quality and
the activity status
1. The activity status will be assessed in 3 different areas: occupational
activities, tasks in the household and leisure activities
2. The life quality is assessed on the basis of the HAQ-DI
Secondary Objectives:
- To record side effects of Tempus tablet when used under everyday conditions
- To collect socioeconomic data such as e.g. aids or applications
;
Observational Model: Cohort, Time Perspective: Prospective
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