Clinical Trial: Kineret CAPS Post Authorisation Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-interventional PASS to Evaluate Safety of Kineret in Treatment of CAPS in Routine Clinical Care With Regard to Serious Infections, Malignancies, Injection Site Reactions, Allergic Reactions, Medic

Brief Summary: A non-interventional, post authorization safety study to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe.

Detailed Summary:
Sponsor: Swedish Orphan Biovitrum

Current Primary Outcome:

  • Rate of serious infections [ Time Frame: 3 years ]
  • Rate of new malignancies [ Time Frame: 3 years ]
  • Rate of injection site reactions [ Time Frame: 3 years ]
  • Rate of allergic reactions [ Time Frame: 3 years ]
  • Rate of medication errors including re-use of syringe [ Time Frame: 3 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Swedish Orphan Biovitrum

Dates:
Date Received: December 1, 2014
Date Started: April 2015
Date Completion: December 2019
Last Updated: August 19, 2016
Last Verified: August 2016