Active clinical trials for "Gout"

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level (SUL). Long-term lowering SUL below 360 µmol/L allows dissolution of deposited crystals and disease cure. There is currently a paradoxical observation: while urate-lowering therapy (ULT) is available and efficient there is an increase of gout prevalence and severity. The apparent failure of ULT in gout management is due to several causes including unadjusted dosage, no SUL verification, irregular follow-up and low treatment compliance. In contrast, a nurse-led treat-to-target (T2T) strategy with regular adaptations of ULT until reaching SUL target allows gout cure in more than 90% of patients. We hypothesize that an electronic messaging-led T2T strategy will allow obtaining similar results. The aim of this study is to demonstrate that email-led T2T strategy during ULT is superior to usual care.

The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Gout is the most common form of rheumatic disease in which monosodium urate crystals are deposited in the joints followed by acute inflammatory reactions. There are various approved drugs that can be prescribed for pain relief during an acute gout attack. However to date, no direct comparison of efficacy of colchicine and prednisolone for the treatment of acute gout attacks has been investigated. Furthermore, majority of previous research studies were not only conducted in tertiary centres but also excluded patients with common comorbidities due to contraindications with naproxen. This pragmatic, prospective, double-blind, parallel-group, randomized, non-inferiority trial will investigate whether prednisolone (treatment drug) is comparable or only acceptably worse than treatment with colchicine (comparison drug) in patients presenting with acute gout. Patients presenting with acute gout to their general practitioners in 60 practices across 3 university sites (Greifswald, Göttingen, and Würzburg) will be invited to participate. Patients often excluded by previous studies due to contraindications with naproxen will also be able to participate. The investigators will compare the absolute levels of the most severe pain on day 3 (in the last 24 hours) measured with an 11-item numerical rating scale as the primary endpoint. Day 0 is the day patients take their study medication for the first time. They are then asked to fill out a study diary at the same time each day to quantify their pain. Pain scores will then be used as comparison between the two medications.

The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult subjects with gout, with or without tophi, and hyperuricemia refractory to SoC XOI therapy.

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Gout is a chronic disease of deposition of monosodium urate crystals, which form in the presence of increased urate concentrations. Gout is closely related to hyperuricaemia. Urate deposits in the joint, causing joint swelling, pain, movement disorders, affecting a significant portion of the population worldwide annually. The underlying pathophysiology of gout is multifactorial, complex, and poorly understood. Thus, gout remains one of the major therapeutic challenges. Currently, western medicine treatment of gout flare includes colchicine, NSAIDs and glucocorticoids. These drugs act as analgesics, anti-inflammatory and uric acid lowering drugs. Besides, management of gout and prevention of acute flares of gout make a crucial part in gout management. To obtain uricemia target, urate lowering treatment (ULT) has been widely used in conventional management of gout. Allopurinol, probenecid and febuxostat are some of the examples of ULT. Although researchers have carried out various studies on this disease, there are severe side effects for patients with gout. Therefore, it is necessary to explore new treatments for gout with good efficacy and less side effects. Chinese medicine (CM) is nowadays widely used for managing gout in China and other East Asian countries. Our principal Investigator (Prof. Zhi-xiu Lin), a highly experienced Registered Chinese Medicine Practitioner working at the School of Chinese Medicine, The Chinese University of Hong Kong, has been using a herbal formula (HKIIM-KU formula) to treat patients with gout in Hong Kong for many years. This formula has been observed to be effective in relieving and preventing gout and its related clinical manifestations. Hence, a double-blind, randomized, placebo-controlled, multicenter clinical trial will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of HKIIM-KU formula for gout.

To evaluate the safety and efficacy of Genakumab for Injection in patients with gout flare as a first line therapy

Gout is secondary to urate crystal deposition after chronic elevation of serum urate level. Urate crystal deposition is responsible for acute and recurrent inflammatory flares which can be treated with colchicine, non-steroid anti-inflammatory drugs (NSAID), corticosteroid or interleukin (IL)-1b blockade. Colchicine and NSAID are contra-indicated in patients with chronic renal disease (CKD) stage 4/5 or with renal transplantation. In these patients gout flare is treated with high dose of corticosteroid or IL-1b inhibitors. Frequent use of high dose of corticosteroid can worsen gout comorbidities including mellitus diabetes type 2, hypertension, obesity and dyslipidemia. Anakinra, an IL-1b receptor antagonist, is efficient in gout flare in patients without CKD stage 4/5. The aim of this study is to demonstrate that anakinra is superior to prednisone to treat gout flare in patients with CKD 4/5 or renal transplantation.