Clinical trials: Gout Chronic
Gout, Chronic Kidney Disease (CKD)
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
- Trial name
- NCT03226899
- Testing
- Lesinurad, XOI, colchicine
- Where
- 116 sites in United States, Czechia and 2 more
- Volunteers
- 242 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Gout
Virtual Gout Clinic
The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout…
- Trial name
- NCT02790463
- Testing
- Pharmacist-Led Intervention
- Where
- 2 sites in United States
- Volunteers
- 1,463 people
- Sponsor
- University of Alabama at Birmingham
Gout
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
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…
- Trial name
- NCT06229145
- Testing
- Pegloticase, Methotrexate
- Where
- 74 sites in United States
- Volunteers
- 306 people
- Sponsor
- Amgen
Uncontrolled Gout, Chronic Gout
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks…
- Trial name
- FORWARD OL (NCT04762498)
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 12 sites in United States
- Volunteers
- 54 people
- Sponsor
- Amgen
Chronic Uncontrolled Gout, Gout
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
- Conditions
- Chronic Uncontrolled Gout, Gout, Uncontrolled Gout
- Trial name
- NCT04511702
- Testing
- Pegloticase with MTX
- Where
- 39 sites in United States
- Volunteers
- 191 people
- Sponsor
- Amgen
Chronic Gout
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months.
- Trial name
- COMPARE (NCT03905512)
- Testing
- SEL-212, KRYSTEXXA®
- Where
- 43 sites in United States
- Volunteers
- 170 people
- Sponsor
- Selecta Biosciences, Inc.
Gout
An Assessment of Chronic Synovial-Based Inflammation and Its Role With Serum Urate Levels.
The purpose of this study is to show that patients with gout suffer from chronic inflammation of their joints, observable by MRI, even in the absence of symptomatic gouty attacks.
- Trial name
- NCT01112982
- Testing
- Magnetic Resonance Imaging, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- University of South Florida
Gout Chronic
REduCing Immunogenicity to PegloticasE (RECIPE) Study
Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to investigate the question of whether a short course of…
- Trial name
- RECIPE (NCT03303989)
- Testing
- Pegloticase 8 MG/ML [Krystexxa], MMF
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Alabama at Birmingham
Refractory Chronic Gout
Observational Study of the Use of Pegloticase (KRYSTEXXA®) in Refractory Chronic Gout
The primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex…
- Trial name
- EyesOnGOUT (NCT01466166)
- Testing
- Pegloticase
- Where
- 67 sites in United States
- Volunteers
- 188 people
- Sponsor
- Horizon Pharma Rheumatology LLC
Chronic Gout, Hyperuricemia
The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics
Subjects will undergo a placebo and allopurinol phase to better understand the effects of the reduced function BCRP Q141K variant on allopurinol pharmacokinetics and pharmacodynamics.
- Trial name
- NCT02956278
- Testing
- Allopurinol
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Gout, Chronic Kidney Diseases
CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
This trial will compare two effective therapies, allopurinol and febuxostat, to lower serum uric acid and therefore prevent further gout attacks. These therapies have never been compared at appropriate doses.
- Trial name
- NCT02579096
- Testing
- allopurinol capsule, 100-800 mg by mouth once daily, febuxostat tablet 40-120 mg by mouth once daily
- Where
- 23 sites in United States
- Volunteers
- 950 people
- Sponsor
- VA Office of Research and Development
Infection, Heart Failure
Rural Home Hospital: Proof of Concept
This study examines the implications of providing hospital-level care in rural homes.
- Conditions
- Infection, Heart Failure, Chronic Obstructive Pulmonary Disease, Asthma
- Trial name
- NCT04531280
- Testing
- Home hospital care
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Brigham and Women's Hospital
Gout Chronic, Hyperuricemia
Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple…
- Trial name
- NCT02959918
- Testing
- SEL-212, SEL-037, SVP-rapamycin (SEL-110)
- Where
- 13 sites in United States
- Volunteers
- 152 people
- Sponsor
- Selecta Biosciences, Inc.
Gout
Open-Label Extension Study for Patients Who Completed a Phase 3 Double-blind Study of PEG-uricase for Symptomatic Gout
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout.
- Trial name
- NCT01356498
- Testing
- pegloticase
- Where
- 22 sites in United States
- Volunteers
- 151 people
- Sponsor
- Savient Pharmaceuticals
Gout
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating…
- Trial name
- NCT00819585
- Testing
- Canakinumab, Colchicine, Allopurinol
- Where
- 89 sites in United States, Argentina and 16 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Gout
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo.
- Trial name
- DISSOLVE II (NCT04596540)
- Testing
- SEL-212 low-dose, SEL-212 high-dose
- Where
- 53 sites in United States, Georgia and 3 more
- Volunteers
- 153 people
- Sponsor
- Swedish Orphan Biovitrum
Chronic Gout
A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy
This is one of two replicate randomized, double-blind, placebo-controlled, parallel arm trials to determine the safety and efficacy of two different dose levels of SEL-212 compared to placebo.
- Trial name
- DISSOLVE I (NCT04513366)
- Testing
- SEL-212 low-dose, SEL-212 high-dose, Normal Saline
- Where
- 40 sites in United States
- Volunteers
- 112 people
- Sponsor
- Swedish Orphan Biovitrum
Chronic Gout Refractory to Conventional Therapy
Re-exposure Study of Pegloticase Intravenous (i.v.) in Symptomatic Gout Patients
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v.
- Trial name
- NCT00675103
- Testing
- pegloticase 8 mg i.v.
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- Savient Pharmaceuticals