Pilot study of efficacy of anakinra in acute gouty arthritis

ISRCTN ISRCTN10862635
DOI https://doi.org/10.1186/ISRCTN10862635
Secondary identifying numbers 2006-1
Submission date
21/11/2006
Registration date
04/01/2007
Last edited
29/11/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alexander So
Scientific

Rheumatology Service
Centre Hospitalier Universitaire Vaudois (CHUV)
Av Pierre Decker
Lausanne
1011
Switzerland

Study information

Study designOpen label pilot study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTreatment with anakinra will decrease the signs and symptoms of acute gout.
Ethics approval(s)Ethics committee approval is pending, approval expected in January 2007.
Health condition(s) or problem(s) studiedAcute gout
InterventionTreatment with 100 mg anakinra daily subcutaneously for three days
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Anakinra
Primary outcome measure1. Pain of arthritis
2. Signs of arthritis
Secondary outcome measuresBiological markers of inflammation
Overall study start date01/12/2006
Completion date31/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants10
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2006
Date of final enrolment31/01/2007

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Rheumatology Service
Lausanne
1011
Switzerland

Sponsor information

University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland)
University/education

Rheumatology
Department of Medicine
University of Lausanne
Lausanne
1011
Switzerland

Phone +41 (0)21 314 14 50
Email secretariat.so@chuv.ch
Website http://www.chuv.ch/
ROR logo "ROR" https://ror.org/05a353079

Funders

Funder type

University/education

Service of Rheumatology of the Centre Hospitalier Universitaire, Vaudois (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/09/2007 Yes No