Rheumatoid Arthritis Clinical Trial
Official title:
Kineret in the Treatment of Rheumatoid Arthritis
Verified date | August 2017 |
Source | Swedish Orphan Biovitrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Informed consent by the patient - Rheumatoid arthritis - Previous methotrexate therapy with inadequate response Exclusion Criteria: - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Germany | Swedish Orphan Biovitrum Investigational Site | Freiburg |
Lead Sponsor | Collaborator |
---|---|
Swedish Orphan Biovitrum |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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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