Anakinra versus treatment as usual in the treatment of acute gout
- Conditions
- GoutTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-000696-27-NL
- Lead Sponsor
- prof. dr. M.A.F.J. van de Laar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
• At least 18 years of age
• Signed written informed consent
• Identification of intracellular monosodium urate crystals in primary joint through aspiration of joint
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
• Absolute contra-indication for urate lowering therapy
• Absolute contra-indication for anakinra
• Presence of liver disease that according to the treating physician precludes participation in the study
• Absolute contra-indication for all three possible standard of care treatments (colchicine, naproxen, prednisolon)
• Known history of allergy or sensitivity to latex
• Current use of any ULT
• Concurrent use of other IL-1 agents
• Patient reports no to mild gout related pain
• Pregnancy or lactation
• Women who are planning on becoming pregnant within the study period (12 months)
• Patients with active or recurrent bacterial, fungal or viral infection
• Patients using tumor necrosis factor inhibitors
• Patient has insufficient knowledge of the Dutch language for completing questionnaire independently
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method