NCT01075711

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,728 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Prednisone	According to SPC

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2010-02-25
• Last updated: 2014-02-19

Locations

1 site across 1 country: Germany