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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono GmbH, Germany
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01075711
First received: February 24, 2010
Last updated: October 4, 2011
Last verified: October 2011

February 24, 2010
October 4, 2011
April 2009
September 2010   (final data collection date for primary outcome measure)
Change in the QAS (Questionnaire on Activity Status) [ Time Frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01075711 on ClinicalTrials.gov Archive Site
  • QAS comparison after 9 months [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
  • Performance by visual analog scale (VAS) [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
  • Concurrent medication [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
  • Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists) [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
  • Laboratory results (c reactive protein [CRP], BSG), X-rays (if available) [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
  • Side-effects and undesirable events [ Time Frame: Beginning until after 9 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood sample

Probability Sample

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.

Arthritis, Rheumatoid
Drug: Prednisone
According to SPC
Other Name: Lodotra
  • 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.
    Intervention: Drug: Prednisone
  • 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.
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2728
November 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01075711
062215-500
Not Provided
Merck KGaA
Merck KGaA
Merck Serono GmbH, Germany
Study Director: Dr. Boris Pfeiffer, M.Sc. Merck Serono GmbH, Germany
Merck KGaA
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP