Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214851
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2005-09-21
Brief Title:
The Use of Kineret Anakinra in the Treatment of Familial Cold Urticaria
Sponsor:
Nova Scotia Health Authority
Organization:
Nova Scotia Health Authority
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 100mgday 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 FCUThis 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 FCUThis 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 NB
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 anakinraon the quality of life of patients with FCU
Study design An open-labelled trial of Kineret anakinra induction therapy 100mgday 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 anakinraon the quality of life of patients with FCU
Study design An open-labelled trial of Kineret anakinra induction therapy 100mgday 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:
None
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?:
None