Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities 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

Official Title
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Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who correspond to the permitted indication of the drug of Lodotra Subjects from age of 18 years with diagnosed, active RA with associated symptoms such as morning stiffness of the joints, which is either already being treated with low dose of glucocorticoids or will be treated again with glucocorticoid therapy Exclusion Criteria: - Subjects with contraindications are excluded from the participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIS in-house doctors<br>This group will be assigned to general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months. Three subjects are expected per in-house doctor therefore altogether, 1000 in-house doctors will be obtained or appointed for the observation study. | Drug: Prednisone<br>* According to SPC<br>* Other names: Lodotra;|
| NIS specialists<br>This group will be assigned to specialists (rheumatologist) with an observation period of 9 months. Ten subjects per rheumatologist are expected therefore altogether, 500 rheumatologists will be obtained or appointed for the observation study. | Drug: Prednisone<br>* According to SPC<br>* Other names: Lodotra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the QAS (Questionnaire on Activity Status) |  | Beginning of the examination (gross-root survey) and after 3 months (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QAS comparison after 9 months |  | Beginning until after 9 months | 
| Performance by visual analog scale (VAS) |  | Beginning until after 9 months | 
| Concurrent medication |  | Beginning until after 9 months | 
| Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists) |  | Beginning until after 9 months | 
| Laboratory results (c reactive protein [CRP], BSG), X-rays (if available) |  | Beginning until after 9 months | 
| Side-effects and undesirable events |  | Beginning until after 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Rheumatoid, Prednisone