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Completed

NCT Number: NCT01075711

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Merck Serono GmbH, Darmstadt, Germany

Darmstadt, 64289, Germany

About this study

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
  • The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

According to SPC

Other names: Lodotra

Primary outcomes

  1. Change in the QAS (Questionnaire on Activity Status)

    Time frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)

Secondary outcomes

  1. QAS comparison after 9 months

    Time frame: Beginning until after 9 months

  2. Performance by visual analog scale (VAS)

    Time frame: Beginning until after 9 months

  3. Concurrent medication

    Time frame: Beginning until after 9 months

  4. Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)

    Time frame: Beginning until after 9 months

  5. Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)

    Time frame: Beginning until after 9 months

  6. Side-effects and undesirable events

    Time frame: Beginning until after 9 months

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono GmbH, Germany

Registry information

Official study 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

Acronym: LODOTRA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2010
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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