Pilot study of efficacy of anakinra in acute gouty arthritis
| ISRCTN | ISRCTN10862635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10862635 |
| Protocol serial number | 2006-1 |
| Sponsor | University Hospital Complex of Vaud (Centre Hospitalier Universitaire Vaudois [CHUV]) (Switzerland) |
| Funder | Service of Rheumatology of the Centre Hospitalier Universitaire, Vaudois (Switzerland) |
- 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
Scientific
Rheumatology Service
Centre Hospitalier Universitaire Vaudois (CHUV)
Av Pierre Decker
Lausanne
1011
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open label pilot study |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study objectives | Treatment 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) studied | Acute gout |
| Intervention | Treatment with 100 mg anakinra daily subcutaneously for three days |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Anakinra |
| Primary outcome measure(s) |
1. Pain of arthritis |
| Key secondary outcome measure(s) |
Biological markers of inflammation |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Rheumatology Service
Lausanne
1011
Switzerland
1011
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
