Condition category
Musculoskeletal Diseases
Date applied
21/11/2006
Date assigned
04/01/2007
Last edited
29/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alexander So

ORCID ID

Contact details

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

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 measures

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

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

http://www.chuv.ch/

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

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17352828

Publication citations

  1. 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.

Additional files

Editorial Notes