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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Prednisone

Study type: Observational

Funder types: Industry

Identifiers

NCT01075711

062215-500

Details and patient eligibility

About

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.

Full 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

Enrollment: 2,728 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,728 participants in 2 patient groups

NIS in-house doctors

Description:

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.

Treatment:

Drug: Prednisone

NIS specialists

Description:

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.

Treatment:

Drug: Prednisone