Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone)
LODOTRA
Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet
1 other identifier
observational
2,728
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 19, 2014
February 1, 2014
1.4 years
February 24, 2010
February 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the QAS (Questionnaire on Activity Status)
Beginning of the examination (gross-root survey) and after 3 months (follow-up)
Secondary Outcomes (6)
QAS comparison after 9 months
Beginning until after 9 months
Performance by visual analog scale (VAS)
Beginning until after 9 months
Concurrent medication
Beginning until after 9 months
Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)
Beginning until after 9 months
Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)
Beginning until after 9 months
- +1 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \- Subjects with contraindications are excluded from the participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Merck KGaA, Darmstadt, Germanylead
- Merck Serono GmbH, Germanycollaborator
Study Sites (1)
Merck Serono GmbH, Darmstadt, Germany
Darmstadt, 64289, Germany
Related 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. Epub 2012 Nov 21.
PMID: 23179262RESULT
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr. Boris Pfeiffer, M.Sc.
Merck Serono GmbH, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2010
First Posted
February 25, 2010
Study Start
April 1, 2009
Primary Completion
September 1, 2010
Study Completion
November 1, 2010
Last Updated
February 19, 2014
Record last verified: 2014-02