Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006-1
Study information
Scientific title
Acronym
Study hypothesis
Treatment with anakinra will decrease the signs and symptoms of acute gout.
Ethics approval
Ethics committee approval is pending, approval expected in January 2007.
Study design
Open label pilot study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Acute gout
Intervention
Treatment with 100 mg anakinra daily subcutaneously for three days
Intervention type
Drug
Phase
Not Specified
Drug names
Anakinra
Primary outcome measure
1. Pain of arthritis
2. Signs of arthritis
Secondary outcome measures
Biological markers of inflammation
Overall trial start date
01/12/2006
Overall trial end date
31/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Acute gout as defined by American College of Rheumatology (ACR) criteria
2. Acute arthritis due to gout which is unresponsive to conventional therapy with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), colchicine or steroids
3. Patients with acute gout who have had side effects or intolerance to either NSAIDs, colchicine or steroids
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Patients with on-going or untreated infectious diseases
2. Patients with rheumatoid arthritis, lupus or vasculitis
3. Patients concurrently treated with anti-Tumour Necrotising Factor (TNF) therapies
4. Patients with active cancer
Recruitment start date
01/12/2006
Recruitment end date
31/01/2007
Locations
Countries of recruitment
Switzerland
Trial participating centre
Rheumatology Service
Lausanne
1011
Switzerland
Sponsor information
Organisation
University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland)
Sponsor details
Rheumatology
Department of Medicine
University of Lausanne
Lausanne
1011
Switzerland
+41 (0)21 314 14 50
secretariat.so@chuv.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Service of Rheumatology of the Centre Hospitalier Universitaire, Vaudois (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17352828
Publication citations
-
Results
So A, De Smedt T, Revaz S, Tschopp J, A pilot study of IL-1 inhibition by anakinra in acute gout., Arthritis Res. Ther., 2007, 9, 2, R28, doi: 10.1186/ar2143.