Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)
- Registration Number
- NCT01075711
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2728
- 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
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- Subjects with contraindications are excluded from the participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NIS in-house doctors Prednisone 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. NIS specialists Prednisone 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.
- Primary Outcome Measures
Name Time Method Change in the QAS (Questionnaire on Activity Status) Beginning of the examination (gross-root survey) and after 3 months (follow-up)
- Secondary Outcome Measures
Name Time Method Laboratory results (c reactive protein [CRP], BSG), X-rays (if available) Beginning until after 9 months 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 Side-effects and undesirable events Beginning until after 9 months
Trial Locations
- Locations (1)
Merck Serono GmbH, Darmstadt, Germany
🇩🇪Darmstadt, Germany