Kineret in the Treatment of Rheumatoid Arthritis

• Sponsor: Swedish Orphan Biovitrum (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02915094
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Anakinra

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Kineret in the Treatment of Rheumatoid Arthritis
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Outcome Measures

Primary Outcome Measures

1. 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".

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Informed consent by the patient

• Rheumatoid arthritis

• Previous methotrexate therapy with inadequate response

Exclusion Criteria:

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Swedish Orphan Biovitrum Investigational Site	Freiburg		Germany

Sponsors and Collaborators

• Swedish Orphan Biovitrum

Investigators

• Study Director: Stefan Zeitler, MD, Swedish Orphan Biovitrum GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Swedish Orphan Biovitrum
• ClinicalTrials.gov Identifier: NCT02915094
• Other Study ID Numbers: KIRA
• First Posted: Sep 26, 2016
• Last Update Posted: Aug 11, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Interleukin 1 Receptor Antagonist Protein

Study Results

No Results Posted as of Aug 11, 2017