Familial Cold UrticariaPhase 1NCT00214851
The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
A Phase 1 study testing Kineret (anakinra) in people with Familial Cold Urticaria, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Familial Cold Urticaria
- What is being tested?
- Kineret (anakinra)
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Dec 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
About this study
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.
Read the 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
- Conditions
- Familial Cold Urticaria
- Being tested
- Kineret (anakinra)
- Keywords
- Familial Cold Urticaria, Kineret (anakinra), Interleukin 1 beta, C-Reactive Protein, Serum Amyloid A protein
- Medical subject headings
- Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kineret (anakinra)Drug
Kineret (anakinra 100 mg. s/c daily x 4 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
Measured: 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
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Cold UrticariaStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Atlantic Provinces Dermatology Association
- Responsible party
- Sponsor
- Investigators
- Laura A. Finlayson MD FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214851
- Sponsor's protocol ID
- CDHA002
- Status last verified
- May 2008
- First submitted
- 21 Sep 2005
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria
- ClinicalTrials.gov ID
- NCT00214851
- Acronym / sponsor ID
- CDHA002
- Conditions
- Familial Cold Urticaria
- Keywords
- Familial Cold Urticaria, Kineret (anakinra), Interleukin 1 beta, C-Reactive Protein, Serum Amyloid A protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Atlantic Provinces Dermatology Association
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kineret (anakinra)Kineret (anakinra 100 mg. s/c daily x 4 weeks | Drug | – |
Primary outcome
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria.
Time frame: Eight weeks
1 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
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
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Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
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Ilaris NIS in Korea
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A. Finlayson MD FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Kineret (anakinra) in people with Familial Cold Urticaria, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of kineret (anakinra) 100mg./day in subjects with familial cold urticaria. (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.