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

February 16, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

2728

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany, 64289
        • Merck Serono GmbH, Darmstadt, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with RA who are treated with Tempus tablet and subjects with re-diagnosed RA are also included in the study, if the RA is treated with glucocorticoides.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NIS in-house doctors
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.
Drug: Prednisone
According to SPC
Other Names:
  • Lodotra
NIS specialists
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.
Drug: Prednisone
According to SPC
Other Names:
  • Lodotra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the QAS (Questionnaire on Activity Status)
Time Frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)
Beginning of the examination (gross-root survey) and after 3 months (follow-up)

Secondary Outcome Measures

Outcome Measure
Time Frame
QAS comparison after 9 months
Time Frame: Beginning until after 9 months
Beginning until after 9 months
Performance by visual analog scale (VAS)
Time Frame: Beginning until after 9 months
Beginning until after 9 months
Concurrent medication
Time Frame: Beginning until after 9 months
Beginning until after 9 months
Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)
Time Frame: Beginning until after 9 months
Beginning until after 9 months
Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)
Time Frame: Beginning until after 9 months
Beginning until after 9 months
Side-effects and undesirable events
Time Frame: Beginning until after 9 months
Beginning until after 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono GmbH, Germany

Investigators

  • Study Director: Dr. Boris Pfeiffer, M.Sc., Merck Serono GmbH, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 24, 2010

First Posted (Estimate)

February 25, 2010

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 16, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062215-500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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