Kineret in the Treatment of Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02915094
• Lead Sponsor: Swedish Orphan Biovitrum

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-09-23
• Study First Submitted QC: 2016-09-23
• Study First Posted: 2016-09-26
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Informed consent by the patient
• Rheumatoid arthritis
• Previous methotrexate therapy with inadequate response

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Swedish Orphan Biovitrum Investigational Site; 🇩🇪 Freiburg, Germany