Clinical Trial: The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria

Brief Summary:

An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four week period in the treatment of Familial Cold Urticaria.

Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms triggered by exposure to cold and variable in expression. Currently there is no standard reliable agent available for the treatment of patients with FCU.This study will evaluate the efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and maintenance therapy in patients with FCU.


Detailed Summary:

Product: Kineret (anakinra) Protocol title: The Use of Kineret (anakinra) in the Treatment of Familial Cold Urticaria (FCU) Target Disease: Familial Cold Urticaria Patients: 8 patients all previously diagnosed with FCU and living close to Moncton, N.B.

Study Objectives:

  • To assess the efficacy of Kineret (anakinra) 100mg. given subcutaneously daily in subjects with FCU.
  • To demonstrate the use of CRP and SAA as objective laboratory markers of the effectiveness of treatment.
  • To determine the effect of Kineret (anakinra)on the quality of life of patients with FCU.

Study design: An open-labelled trial of Kineret (anakinra) induction therapy (100mg./day) over a four week period.

Treatment regimens: After initial clinical and laboratory assessment, the patients will receive Kineret (anakinra) 100mg. daily for four weeks. They will be observed for two further weeks without the medication.

Route of administration: Subcutaneous injection Interval between first and last dose of active study agent: 4 weeks Duration of study participation: 8 weeks Number of subjects: 8 Number of sites: 1 Interim analysis: Daily patient diary; weekly follow-up phone calls; CRP reports


Sponsor: Nova Scotia Health Authority

Current Primary Outcome: To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria. [ Time Frame: Eight weeks ]

Original Primary Outcome: To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.

Current Secondary Outcome: To demonstrate the use of C-Reactive Protein (CRP) and Serum Amyloid A Protein (SAA) levels as objective laboratory indicators of effective treatment and to compare the results of two different laboratory methods for the estimation of CRP [ Time Frame: Eight weeks ]

Original Secondary Outcome: To demonstrate the use of C-Reactive Protein (CRP) and Serum Amyloid A Protein (SAA) levels as objective laboratory indicators of effective treatment and to compare the results of two different laboratory methods for the estimation of CRP

Information By: Nova Scotia Health Authority

Dates:
Date Received: September 21, 2005
Date Started: September 2005
Date Completion:
Last Updated: May 30, 2008
Last Verified: May 2008