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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00214851
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 2, 2008
Atlantic Provinces Dermatology Association
Information provided by:
Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment Phase
Familial Cold Urticaria Drug: Kineret (anakinra) Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
Study Start Date : September 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Intervention Details:
  • Drug: Kineret (anakinra)
    Kineret (anakinra 100 mg. s/c daily x 4 weeks

Primary Outcome Measures :
  1. To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria. [ Time Frame: Eight weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00214851

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Canada, Nova Scotia
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Sponsors and Collaborators
Nova Scotia Health Authority
Atlantic Provinces Dermatology Association
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Principal Investigator: Laura A. Finlayson MD FRCPC Nova Scotia Health Authority

Layout table for additonal information Identifier: NCT00214851     History of Changes
Other Study ID Numbers: CDHA002
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 2, 2008
Last Verified: May 2008

Keywords provided by Nova Scotia Health Authority:
Familial Cold Urticaria
Kineret (anakinra)
Interleukin 1 beta
C-Reactive Protein
Serum Amyloid A protein

Additional relevant MeSH terms:
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Cryopyrin-Associated Periodic Syndromes
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents