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

Information source: Capital District Health Authority, Canada
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Familial Cold Urticaria

Intervention: Kineret (anakinra) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Capital District Health Authority, Canada

Official(s) and/or principal investigator(s):
Laura A. Finlayson MD FRCPC, Principal Investigator, Affiliation: Capital District Health Authority

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must be 18 years of age or older at the time of enrollment; may be male or female

- Must be previously diagnosed with Familial Cold Urticaria (FCU)

- Must react with at least one of the symptoms of FCU in the summer months at least four

times per week sufficiently to interfere with ordinary daily activities or inhibit normal life enjoyment.

- Women must be willing to have a pregnancy test and if necessary, use contraceptive

measures.

Exclusion Criteria:

- Receiving any systemic medications/treatments that could affect FCU.

- Pregnancy, nursing or planning pregnancy, or, have recently been pregnant to less than

three months development and with a history of serious birth defect.

- Have had any previous treatment with Kineret (anakinra) or any therapeutic agent

targeted at IL-1 blockade.

- Have used any investigational drug within the previous 1 month or five times the half

life of the investigational agent, whichever is longer, or 3 months for any biologic of unknown half life.

- Have received any systemic medication or treatments that could affect the symptoms of

FCU such as antihistamines, corticosteroid drugs, NSAIDS, anabolic medications or Ketotifen within 2 weeks of the baseline visit.

- Have any known malignancy or have a history of malignancy within the previous five

years (with the exception of basal or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence).

Locations and Contacts

Queen Elizabeth Health Sciences Centre, Halifax, Nova Scotia B3H 1V7, Canada
Additional Information

Starting date: September 2005
Ending date: December 2005
Last updated: May 30, 2008

Page last updated: June 20, 2008

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