- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00214851
The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Queen Elizabeth Health Sciences Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
Time Frame: Eight weeks
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Eight weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: Eight weeks
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Eight weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura A. Finlayson MD FRCPC, Nova Scotia Health Authority
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Cryopyrin-Associated Periodic Syndromes
- Antirheumatic Agents
- Interleukin 1 Receptor Antagonist Protein
Other Study ID Numbers
- CDHA002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Familial Cold Urticaria
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Regeneron PharmaceuticalsCompletedGenetic Diseases, Inborn | Familial Cold Autoinflammatory Syndrome (FCAS) | Familial Cold Urticaria | Muckle-Wells Syndrome (MWS)United States
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Yuhan CorporationRecruitingAllergic Disease | Chronic Spontaneous Urticaria | Cold Urticaria | Chronic Inducible UrticariaKorea, Republic of
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SanofiRegeneron PharmaceuticalsCompletedCold UrticariaUnited States, Argentina, Canada, Germany, Japan
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