Clinical trials: Gout Chronic
Gout, Gouty Arthritis
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase).
- Conditions
- Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic
- Trial name
- NCT07116746
- Testing
- AR882 75 mg, XOI Low Dose, XOI High Dose
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Arthrosi Therapeutics
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
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
Gout, Arthritis, Gouty
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT05253833
- Testing
- AR882 Dose 1, AR882 Dose 2, Allopurinol Tablet
- Where
- 12 sites in United States, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Arthrosi Therapeutics
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.
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
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
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
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06846515
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 83 sites in United States
- Volunteers
- 866 people
- Sponsor
- Arthrosi Therapeutics
Gout, Arthritis, Gouty
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
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 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT05119686
- Testing
- AR882 Dose 1, AR882 Dose 2
- Where
- 23 sites in United States, Australia and 1 more
- Volunteers
- 140 people
- Sponsor
- Arthrosi Therapeutics
Gout
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients with chronic, refractory gout.
- Trial name
- TRIPLE (NCT02598596)
- Testing
- Pegloticase, Azathioprine
- Where
- 11 sites in United States
- Volunteers
- 132 people
- Sponsor
- Ampel BioSolutions, LLC
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
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
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06439602
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 68 sites in United States, Australia and 3 more
- Volunteers
- 818 people
- Sponsor
- Arthrosi Therapeutics
Hyperuricemia, Gout
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Trial name
- NCT04987294
- Testing
- ALLN-346
- Where
- 17 sites in United States
- Volunteers
- 19 people
- Sponsor
- Allena Pharmaceuticals
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 Chronic, Gout
Drug-Drug Interaction Study of ABP-671 in Gout Patients
This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients.
- Conditions
- Gout Chronic, Gout, DDI (Drug-Drug Interaction)
- Trial name
- NCT07367971
- Testing
- ABP-671 plus allopurinol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Atom Therapeutics Co., Ltd
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
Acute Gouty Arthritis
Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult…
- Trial name
- NCT01593527
- Testing
- ACZ885, Triamcinelone acetonide
- Sponsor
- Novartis 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