Clinical trials: Gout Flares
Gout
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy.
- Trial name
- NCT00856206
- Testing
- Rilonacept
- Where
- 124 sites in United States, Germany and 4 more
- Volunteers
- 1,315 people
- Sponsor
- Regeneron Pharmaceuticals
Acute Gouty Arthritis
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
- Trial name
- NCT01356602
- Testing
- Canakinumab pre-filled syringe, Canakinumab lyophilized powder, Triamcinolone Acetonide
- Where
- 99 sites in United States, Canada and 3 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Gouty Arthritis
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent…
- Trial name
- NCT01362608
- Testing
- Canakinumab, ACZ885, Triamcinolone acetonide
- Where
- 20 sites in Argentina, China and 2 more
- Volunteers
- 136 people
- 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
Acute Gouty Arthritis
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
- Trial name
- NCT01431638
- Testing
- Canakinumab 150mg in prefilled syringe
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Gout
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout.
- Trial name
- NCT00958438
- Testing
- Rilonacept
- Where
- 61 sites in Germany, India and 3 more
- Volunteers
- 248 people
- Sponsor
- Regeneron Pharmaceuticals
Acute Gout
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine.
- Trial name
- NCT00798369
- Testing
- Canakinumab, Triamcinolone acetonide
- Where
- 75 sites in United States, Argentina and 9 more
- Volunteers
- 200 people
- Sponsor
- Novartis
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study
The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom…
- Trial name
- β-RELIEVED (NCT01029652)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 47 sites in Australia, Belgium and 15 more
- Volunteers
- 230 people
- Sponsor
- Novartis Pharmaceuticals
Gout
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment.
- Trial name
- NCT00610363
- Testing
- Rilonacept
- Where
- 34 sites in United States
- Volunteers
- 83 people
- Sponsor
- Regeneron Pharmaceuticals
Gout
Novel Methods for Ascertainment of Gout Flares -A Pilot Study
The purpose of this study is to determine the feasibility and acceptability of using different remote data collection technologies to ascertain flare occurrence among gout patients.
- Trial name
- NCT02855437
- Testing
- IVR (Phone call), RheumPro (Smartphone application)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Acute Gouty Arthritis Flares
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any…
- Trial name
- β-RELIEVED (NCT01470989)
- Testing
- ACZ885, Triamcinolone acetonide 40 mg
- Where
- 56 sites in United States, Australia and 7 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal…
- Trial name
- β-RELIEVED-II (NCT01080131)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 108 sites in United States, Canada and 3 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Gout
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
- Trial name
- UPSURGE (NCT01459796)
- Testing
- Rilonacept, Allopurinol
- Where
- 74 sites in United States
- Volunteers
- 220 people
- Sponsor
- Regeneron Pharmaceuticals
Gout Flares
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the inflammatory response in gouty arthritis.
- Trial name
- NCT01712204
- Testing
- AC-201, Febuxostat
- Where
- Taiwan
- Volunteers
- 82 people
- Sponsor
- TWi Biotechnology, Inc.
Gouty Arthritis
Long Term Study of Canakinumab (ACZ885) in Patients With Gout
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all…
- Trial name
- NCT00927810
- Testing
- Canakinumab
- Where
- 45 sites in United States, Argentina and 16 more
- Volunteers
- 341 people
- Sponsor
- Novartis Pharmaceuticals
Intercritical Gout
Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol
The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.
- Trial name
- NCT01451645
- Testing
- Colchicine (Colcrys®), allopurinol
- Where
- 37 sites in United States
- Volunteers
- 82 people
- Sponsor
- Regeneron Pharmaceuticals
Intercritical Gout
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout.
- Trial name
- PRE-SURGE1 (NCT00829829)
- Testing
- Rilonacept 80 mg, Rilonacept 160 mg
- Where
- 91 sites in United States, Canada
- Volunteers
- 241 people
- Sponsor
- Regeneron Pharmaceuticals