Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGAnakinra
Sponsors
Swedish Orphan Biovitrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent by the patient * Rheumatoid arthritis * Previous methotrexate therapy with inadequate response
Exclusion criteria
* Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28 (DAS28) | 0-52 weeks | 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. |
| ACR response | 0-52 weeks | 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. |
| Health Assessment Questionnaire | 0-52 weeks | The patients will at each visit complete a questionnaire about their health status and the impairment in usual activities due to the rheumatoid disorder. |
Countries
Germany
Outcome results
None listed