Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT00214851
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2005-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: