NCT00214851

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Familial Cold Urticaria

Interventions

Type	Name	Description
DRUG	Kineret (anakinra)	Kineret (anakinra 100 mg. s/c daily x 4 weeks

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-22
• Last updated: 2022-11-08

Locations

1 site across 1 country: Canada