Clinical investigation of medicinal products for the treatment of gout - Scientific guideline

The main aim of the guideline is to address general guidance on the development of medicinal products for the treatment of gout. This guideline should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.

Keywords: gout, urate lowering therapy, tophi, chronic tophaceous arthropathy.

Current version

Guideline on clinical investigation of medicinal products for the treatment of gout - First version

Adopted Reference Number: EMA/CHMP/774470/2018 Legal effective date: 01/06/2020

Document history

Guideline on clinical investigation of medicinal products for the treatment of gout - First version

Adopted Reference Number: EMA/CHMP/774470/2018 Legal effective date: 01/06/2020

Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version

Draft: consultation closed Consultation dates: 08/02/2019 to 31/08/2019 Reference Number: EMA/CHMP/774470/2018 Summary:

The main aim of the guideline is to address general guidance on the development of medicinal products for the treatment of gout. This guideline should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.

Standard of care treatment of gout consists of urate-lowering therapy (ULT). Acute flares are treated with analgesics and anti-inflammatory drugs. In addition, prophylactic treatment with NSAIDs or other drugs is frequently given at the start of ULT, as a sudden drop in uric acid levels induced by ULT may precipitate an acute attack of gout.

In this document, guidance is provided on the clinical development of new ULT and anti-inflammatory treatment options. The study design, inclusion criteria, primary endpoints and trial duration largely depend on the treatment goal and mode of action of the new drug.

Concept paper on the need of the guideline on clinical investigation of medicinal products for the treatment of gout - First version

Draft: consultation closed Consultation dates: 14/06/2012 to 30/09/2012 Reference Number: EMA/CHMP/937321/2011 Summary:

At present no Committee for Medicinal Products for Human Use (CHMP) guideline has been developed for the clinical development of medicinal products aiming at prevention and / or treatment of gout and / or hyperuricaemia (e.g. urate lowering therapy (ULT) to treat or prevent acute gout flares). A CHMP guidance is needed to express the current state of scientific knowledge in this guideline.