Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Arthritis, Rheumatoid
 Drug: Prednisone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Drug Information available for: Prednisone
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood sample


Enrollment: 2728
Study Start Date: April 2009
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Lodotra

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075711

Locations
Germany
Merck Serono GmbH, Darmstadt, Germany
Darmstadt, Germany, 64289
Sponsors and Collaborators
Merck KGaA
Merck Serono GmbH, Germany
Investigators
Study Director: Dr. Boris Pfeiffer, M.Sc. Merck Serono GmbH, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01075711     History of Changes
Other Study ID Numbers: 062215-500
Study First Received: February 24, 2010
Last Updated: October 4, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Merck KGaA:
Arthritis, Rheumatoid
Prednisone

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013