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| Name | Class |
|---|---|
| Merck Serono GmbH, Germany | INDUSTRY |
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
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | According to SPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the QAS (Questionnaire on Activity Status) | Beginning of the examination (gross-root survey) and after 3 months (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| QAS comparison after 9 months | Beginning until after 9 months | |
| Performance by visual analog scale (VAS) | Beginning until after 9 months | |
| Concurrent medication |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Boris Pfeiffer, M.Sc. | Merck Serono GmbH, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Serono GmbH, Darmstadt, Germany | Darmstadt | 64289 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23179262 | Result | 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. |
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Blood sample
| 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 |
| Side-effects and undesirable events | Beginning until after 9 months |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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