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Gout clinical trials

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NCT ID: NCT06439602 Recruiting - Gout Clinical Trials

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients

Start date: June 2024
Phase: Phase 3
Study type: Interventional

This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months

NCT ID: NCT06298071 Recruiting - Gout Clinical Trials

A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.

Start date: March 3, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.

NCT ID: NCT06258213 Recruiting - Gout Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers

ABP-745
Start date: January 3, 2024
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled, dose-escalation study will be conducted in healthy volunteers. This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ABP-745 following single (Part 1) and multiple (Part 2) oral doses.

NCT ID: NCT06235710 Recruiting - Clinical trials for Rheumatoid Arthritis

Prevalence of Musculoskeletal Complaints in Nursing Home Residents

Start date: January 18, 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to investigate the prevalence of joint complaints in nursing home residents with and without dementia. Primary objective: Number of tender or swollen joints. Secondary objectives: 1. Only when it is possible for the nursing home resident to provide us this information: how nursing home residents themselves assess the severity of their joint complaints that day (at that time). If the nursing home resident cannot answer this question (reliably), we use the Pain Assessment Checklist for Seniors with Severe Dementia (PACSLAC-D). 2. Investigate mobility limitations among nursing home residents. 3. To understand whether an accurate (differential) diagnosis for the joint complaints is reported in the electronic files. During the study, a standard physical examination of the musculoskeletal system will performed. Nursing home residents allocated in group 1 (no dementia) also provide an answer on 3 non-incriminating questions (severity of joint complaints, pain in general and general health). Nursing home residents allocated in group 2 (dementia) answer, if possible, 1 non-incriminating question (pain in joints at that moment). These question(s) and the physical examination are also widely used in daily clinical practice. No further incriminating questions or questionnaires will be administered. If the nursing home resident cannot answer this question (reliably), we use the PACSLAC-D.

NCT ID: NCT06229145 Recruiting - Gout Clinical Trials

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Start date: January 22, 2024
Phase: Phase 4
Study type: Interventional

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time.

NCT ID: NCT06211322 Recruiting - Gout Clinical Trials

The Remote Monitoring of Gout Feasibility Study

ReMonit Gout
Start date: February 27, 2024
Phase: N/A
Study type: Interventional

In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.

NCT ID: NCT06056570 Recruiting - Gout Clinical Trials

Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients With Hyperuricemia

Start date: October 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effects on serum uric acid and urinary urate excretion in U.S. patients with gout and hyperuricemia

NCT ID: NCT05936268 Recruiting - Gout Flare Clinical Trials

Safety and Efficacy of Genakumab for Injection in Patients With Gout Flare

Gensci 048-203
Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT05927688 Recruiting - Clinical trials for Rheumatoid Arthritis

Assessment of Physician Consideration of ePRO's, From Patients With Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus, on the Frequency of Therapeutic Adjustments

CAPTAIN
Start date: July 18, 2023
Phase:
Study type: Observational

Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation. Regular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts). The hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.

NCT ID: NCT05818085 Recruiting - Gout Clinical Trials

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

Start date: August 11, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

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.