Arthritis, Rheumatoid
Conditions
Keywords
Arthritis, Rheumatoid, Prednisone
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
Interventions
DRUGPrednisone
According to SPC
Sponsors
Merck Serono GmbH, Germany
Merck KGaA, Darmstadt, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the QAS (Questionnaire on Activity Status) | Beginning of the examination (gross-root survey) and after 3 months (follow-up) |
Secondary
| Measure | Time frame |
|---|---|
| Performance by visual analog scale (VAS) | Beginning until after 9 months |
| Concurrent medication | Beginning until after 9 months |
| QAS comparison after 9 months | 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 |
| Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists) | Beginning until after 9 months |
Countries
Germany
Outcome results
None listed