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

Arthritis, Rheumatoid Clinical Trial

— LODOTRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075711
• Other study ID #: 062215-500
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 16, 2014
• Start date: April 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2728
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Prednisone
According to SPC

Locations

Country	Name	City	State
Germany	Merck Serono GmbH, Darmstadt, Germany	Darmstadt

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono GmbH, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfeiffer BM, Krenzer S, Dockhorn R, Schwenke R, Schwenke H, Waehrisch J, Kraus E. Impact of modified-release prednisone on functional ability in patients with rheumatoid arthritis. Rheumatol Int. 2013 Jun;33(6):1447-54. doi: 10.1007/s00296-012-2583-1. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the QAS (Questionnaire on Activity Status)		Beginning of the examination (gross-root survey) and after 3 months (follow-up)	No
Secondary	QAS comparison after 9 months		Beginning until after 9 months	Yes
Secondary	Performance by visual analog scale (VAS)		Beginning until after 9 months	Yes
Secondary	Concurrent medication		Beginning until after 9 months	Yes
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)		Beginning until after 9 months	Yes
Secondary	Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)		Beginning until after 9 months	Yes
Secondary	Side-effects and undesirable events		Beginning until after 9 months	Yes