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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01075711
Date of registration: 24/02/2010
Prospective Registration: No
Primary sponsor: Merck KGaA
Public title: Determine the Improvement in Activity Status/Quality of Life (QoL) of Patients With Rheumatoid Arthritis (RA) During Treatment With Lodotra (Prednisone) LODOTRA
Scientific 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
Date of first enrolment: April 2009
Target sample size: 2728
Recruitment status: Completed
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Name:     Dr. Boris Pfeiffer, M.Sc.
Affiliation:  Merck Serono GmbH, Germany
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arthritis, Rheumatoid
Drug: Prednisone
Primary Outcome(s)
Change in the QAS (Questionnaire on Activity Status) [Time Frame: Beginning of the examination (gross-root survey) and after 3 months (follow-up)]
Secondary Outcome(s)
Concurrent medication [Time Frame: Beginning until after 9 months]
Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists) [Time Frame: Beginning until after 9 months]
Laboratory results (c reactive protein [CRP], BSG), X-rays (if available) [Time Frame: Beginning until after 9 months]
Performance by visual analog scale (VAS) [Time Frame: Beginning until after 9 months]
QAS comparison after 9 months [Time Frame: Beginning until after 9 months]
Side-effects and undesirable events [Time Frame: Beginning until after 9 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Merck Serono GmbH, Germany
Ethics review
Results available:
Date Posted:
Date Completed:
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