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Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anakinra | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Activity Score 28 (DAS28) | The DAS28 measures the progress and improvement of Rheumatoid Arthritis. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission. Both the number of joints with tenderness upon touching and swelling are counted. In addition, the erythrocyte sedimentation rate is measured. Also, the patient makes a subjective assessment of disease activity during the preceding 7 days on a scale between 0 and 100, where 0 is "no activity" and 100 is "highest activity possible". | 0-52 weeks |
| ACR response | The ACR (American College of Rheumatology) Criteria measures the effectiveness of treatments for Rheumatoid Arthritis. The ACR is reported as % improvement, comparing disease activity at two discrete time points. | 0-52 weeks |
| Health Assessment Questionnaire | The patients will at each visit complete a questionnaire about their health status and the impairment in usual activities due to the rheumatoid disorder. | 0-52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult male and female patients with rheumatoid Arthritis who are treated with Kineret according to the therapeutic decision of the attending physician.
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Zeitler, MD | Swedish Orphan Biovitrum GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Orphan Biovitrum Investigational Site | Freiburg im Breisgau | Germany |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |