Kineret in the Treatment of Rheumatoid Arthritis

NCT02915094 | Completed

• 1 other identifier: KIRA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Anakinra DRUG

Also known as: Kineret

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male and female patients with rheumatoid Arthritis who are treated with Kineret according to the therapeutic decision of the attending physician.

You may qualify if:

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

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Swedish Orphan Biovitrum: lead

Study Sites (1)

Swedish Orphan Biovitrum Investigational Site

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Stefan Zeitler, MD

  Swedish Orphan Biovitrum GmbH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (1)