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

NCT00214851 | Completed Phase 1

• 1 other identifier: CDHA002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Cold Urticaria

Keywords

Familial Cold Urticaria; Kineret (anakinra); Interleukin 1 beta; C-Reactive Protein; Serum Amyloid A protein

Outcome Measures

Primary Outcomes (1)

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

  Eight weeks

Secondary Outcomes (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

  Eight weeks

Interventions

Kineret (anakinra) DRUG

Kineret (anakinra 100 mg. s/c daily x 4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• Atlantic Provinces Dermatology Association: collaborator

Study Sites (1)

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Cryopyrin-Associated Periodic Syndromes

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Chronic Inducible Urticaria; Chronic Urticaria; Urticaria; Skin Diseases, Vascular; Cold Urticaria; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Laura A. Finlayson MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: November 8, 2022

Record last verified: 2008-05

Locations

CA (1)