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
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