Status:
COMPLETED
The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Atlantic Provinces Dermatology Association
Conditions:
Familial Cold Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 d...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00214851
Start Date
September 1 2005
End Date
December 1 2005
Last Update
November 8 2022
Active Locations (1)
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1
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7