The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria|
- To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria. [ Time Frame: Eight weeks ]
- 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 ]
|Study Start Date:||September 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Drug: Kineret (anakinra)
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00214851
|Canada, Nova Scotia|
|Queen Elizabeth Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Principal Investigator:||Laura A. Finlayson MD FRCPC||Nova Scotia Health Authority|