Ongoing Clinical Trials for Gout
This article provides detailed information about 6 ongoing clinical trials investigating various treatments for gout, a type of arthritis characterized by sudden, severe joint pain and inflammation. These studies are exploring different medications including dapansutrile, febuxostat, prednisolone, colchicine, allopurinol, benzbromarone, and tigulixostat, with trials conducted across multiple European countries.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Espagne
- France
- Study of Dapansutrile and Paracetamol for Patients with Acute Gout Flare
- Study on Gout: Comparing Immediate vs. Delayed Use of Febuxostat for Patients with Acute Gout Attacks
- Study on Stopping Allopurinol or Febuxostat in Gout Patients in Remission
- Study on the Effects of Tigulixostat and Allopurinol in Patients with Gout and High Uric Acid Levels
- Germany
- Italy
- Lithuania
- Netherlands
- Poland
- Spain
Study of Dapansutrile and Paracetamol for Patients with Acute Gout Flare
This trial is investigating dapansutrile, a new anti-inflammatory medication, for treating acute gout flares. The study focuses on patients experiencing sudden, severe joint pain that began within the last 96 hours.
Main inclusion criteria: Adults aged 18 years or older with a confirmed clinical diagnosis of gout, either through the presence of monosodium urate crystals in joint fluid or imaging evidence of urate deposits. Participants must have a current gout flare in a target joint with pain levels of at least 50 mm on a 0-100 scale, along with at least two additional symptoms such as warmth or swelling. Overall acceptable heart, kidney, and liver health is required.
Main exclusion criteria: Patients not experiencing an acute gout flare, those outside the specified age range, and members of vulnerable populations cannot participate.
Trial focus: The primary goal is to evaluate how effectively dapansutrile reduces joint pain 72 hours after the initial dose compared to a placebo. This double-blind study also uses paracetamol as an additional pain reliever. Participants will be monitored at multiple time points including 12, 24, 36, 48, and 60 hours after treatment, as well as on Days 8 and 15. Assessments will include pain intensity, joint tenderness, swelling, and overall health questionnaires.
Investigational drug: Dapansutrile is an oral tablet that works by inhibiting a specific protein involved in inflammation, helping to decrease swelling and pain in affected joints.
Study on Gout: Comparing Immediate vs. Delayed Use of Febuxostat for Patients with Acute Gout Attacks
This French study compares two timing strategies for starting febuxostat treatment: immediately after an acute gout attack versus six weeks after the attack. Febuxostat is a medication that lowers uric acid levels in the blood.
Main inclusion criteria: Adults aged 18 years or older experiencing a gout attack diagnosed immediately or within the last 5 days. The attack must affect one or more peripheral joints (such as hands or feet). Blood uric acid levels must be 420 micromoles per liter or higher, measured within 10 days before joining. Kidney function must show a creatinine clearance of at least 30 milliliters per minute. Women of childbearing potential must use effective contraception and have a negative pregnancy test.
Main exclusion criteria: Patients not experiencing a current gout attack, those under 18 years old, those unable to provide consent, pregnant or breastfeeding women, and individuals with severe kidney or liver problems. People with recent heart problems, uncontrolled high blood pressure, history of substance abuse, or allergies to febuxostat are also excluded.
Trial focus: The study measures the number of days participants experience gout symptoms over approximately six weeks, tracked through daily logbooks. Pain levels are assessed using a specific scale at Days 14, 42, 84, and 182. Additional evaluations include questionnaires about physical function and treatment tolerance, with monitoring for side effects throughout the study period extending to May 2027.
Investigational drug: Febuxostat Viatris 80 mg film-coated tablets work by inhibiting xanthine oxidase, an enzyme that produces uric acid, thereby reducing uric acid levels in the blood and helping to prevent gout attacks.
Study on Treating Acute Gout Attacks with Prednisolone and Colchicine for Primary Care Patients
This German study compares two established medications for treating acute gout attacks: prednisolone (a corticosteroid) and colchicine (an anti-gout agent). The trial is designed for primary care patients.
Main inclusion criteria: Adults aged 18 years or older experiencing acute pain in the hand or foot that began no more than 2 calendar days ago. Participants must have a clinical diagnosis of an acute gout attack confirmed by a doctor. They must be willing to participate and capable of providing written informed consent.
Main exclusion criteria: Patients not experiencing a gout attack, those younger than 18 or older than 65, those not experiencing severe pain in the last 24 hours (below the specified threshold on a 0-10 scale), and members of vulnerable populations are excluded.
Trial focus: The double-blind study evaluates the effectiveness of each treatment in managing the most severe pain experienced during an acute attack. Participants take medication orally for up to five days. Researchers monitor pain levels from Day 1 to Day 6, along with joint swelling, tenderness, and physical function compared to baseline. The study also records participants’ overall assessment of treatment success and tracks use of additional pain relief methods.
Investigational drugs: Prednisolone is a corticosteroid that suppresses the immune system and reduces inflammation. Colchicine works by disrupting microtubule formation, thereby reducing white blood cell activity that contributes to inflammation.
Study on Stopping Allopurinol or Febuxostat in Gout Patients in Remission
This French study investigates whether patients whose gout is in remission can safely stop taking urate-lowering medications (allopurinol or febuxostat) without experiencing new gout flares, using ultrasound monitoring to assess remission status.
Main inclusion criteria: Adults aged 18 years or older with gout diagnosed according to 2015 guidelines. Participants must have been flare-free for at least 2 years, have no tophi (lumps formed by uric acid crystals), and have been taking allopurinol or febuxostat for at least 2 years with serum uric acid levels at or below 60 mg/l. Ultrasound scans at the first visit must show no urate deposits at the big toe joints or knees. Participants must have health insurance and be able to provide informed consent.
Main exclusion criteria: Non-adults, those without confirmed gout, patients not in remission, and members of vulnerable populations cannot participate.
Trial focus: The two-year study compares the risk of gout flares between patients who continue their medication versus those who stop. Regular assessments occur at 6-month intervals (months 6, 12, 18, 24, 30, and 36) to monitor for flares and other health indicators. Ultrasound scans check for urate deposits, and blood tests measure urate levels. The primary outcome is the proportion of participants experiencing gout flares at two years, with additional assessments of health-related quality of life and kidney function. The study is expected to conclude by February 2029.
Investigational drugs: Allopurinol and febuxostat are both xanthine oxidase inhibitors that reduce uric acid production, helping to prevent gout attacks when taken long-term.
Study on Gout Treatment: Comparing Allopurinol, Benzbromarone, and Febuxostat in Patients with Gout in Remission
This Dutch study compares two management strategies for patients with gout in remission: continuing urate-lowering therapy versus stopping it. The study examines three medications: allopurinol, benzbromarone, and febuxostat.
Main inclusion criteria: Adults aged 18 years or older, mentally competent and able to provide written informed consent. Participants must have a clinical diagnosis of gout or meet 2015 ACR-EULAR gout criteria. They must have achieved remission for at least 12 months, defined as being free of flares and clinically apparent tophi during the last 12 months, with serum urate levels at or below 0.36 mmol/l at baseline and all measurements in the last 12 months. Pain due to gout must be less than 2 on a 10-point scale, and disease activity assessment must also be less than 2 on a 10-point scale.
Main exclusion criteria: Patients with conditions other than gout, those outside the specified age range, and members of vulnerable populations are excluded.
Trial focus: Over 24 months, the study assesses what proportion of participants in each group continue to meet adapted remission criteria during the last six months. The criteria include no tophi, no flares, pain less than 2 on a 10-point scale, and disease activity less than 2, independent of serum urate level. If superiority of one strategy is not demonstrated, a secondary analysis will explore non-inferiority. The study also evaluates the cost-effectiveness of each strategy.
Investigational drugs: Allopurinol, benzbromarone, and febuxostat are all urate-lowering therapies that work by different mechanisms to reduce uric acid levels and prevent gout attacks when taken regularly.
Study on the Effects of Tigulixostat and Allopurinol in Patients with Gout and High Uric Acid Levels
This large international study compares a new medication, tigulixostat, against the established treatment allopurinol in patients with gout and hyperuricemia (high uric acid levels). The trial includes participants from multiple European countries.
Main inclusion criteria: Adults aged 18 to 85 years with hyperuricemia and a history or presence of gout according to specific medical criteria. Participants currently on urate-lowering therapy must have serum uric acid levels of 6.0 mg/dL or higher at the first screening visit, while those not on such therapy must have levels of 7.0 mg/dL or higher. After a washout period for those previously on treatment, uric acid levels must reach 7.0 mg/dL or higher. Body Mass Index must be 50 kg/m² or less, and kidney function (eGFR) must be 30 mL/min/1.73m² or higher at the first screening visit. Written consent from the participant or their legally acceptable representative is required.
Main exclusion criteria: Patients with conditions other than gout with hyperuricemia, those outside the 18-85 age range, individuals not belonging to the specific clinical trial group, and members of vulnerable populations are excluded.
Trial focus: After initial assessment and medication washout for those on prior treatment, participants are randomly assigned to receive either tigulixostat tablets or allopurinol capsules. Allopurinol dosages can be adjusted up to 800 mg per day based on individual needs. The treatment phase lasts several months with regular monitoring of serum uric acid levels at months 4, 5, and 6. The primary goal is to determine if tigulixostat can help achieve and maintain uric acid levels below 6 mg/dL. Follow-up assessments continue for 12 months, tracking gout flares, resolution of tophi, and monitoring for side effects through physical examinations and laboratory tests.
Investigational drugs: Tigulixostat is a new xanthine oxidase inhibitor being tested for its ability to reduce uric acid production. Allopurinol is a well-established xanthine oxidase inhibitor widely used to manage high uric acid levels by preventing the conversion of purines into uric acid.
Summary
These six clinical trials represent a comprehensive investigation into various aspects of gout treatment, from managing acute flares to maintaining long-term remission. The studies can be grouped into two main categories: those focused on treating acute attacks and those examining long-term management strategies.
Three trials focus on acute gout flares, testing dapansutrile with paracetamol, comparing febuxostat timing strategies, and evaluating prednisolone versus colchicine. These studies aim to identify more effective ways to relieve the sudden, severe pain associated with gout attacks.
The remaining three trials investigate long-term management in patients whose gout is in remission, examining whether urate-lowering therapy can be safely stopped or comparing the effectiveness of different medications like tigulixostat, allopurinol, benzbromarone, and febuxostat.
France hosts the most trials with four studies, followed by Spain, Germany, and the Netherlands. The large tigulixostat study is particularly notable for its international scope, spanning 10 countries across Europe. The diversity of medications being studied reflects ongoing efforts to optimize gout treatment and improve outcomes for patients at different stages of the disease.
