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.
Public ClinicalTrials.gov record NCT01080131. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Controlled Study of ACZ885 (Canakinumab) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/or Colchicine Are Contraindicated, Not Tolerated or Ineffective Including a 12 Weeks Extension Study and a 1 Year Open-label Extension Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357. The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.
Study identification
- NCT ID
- NCT01080131
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 226 participants
Conditions and interventions
Conditions
Interventions
- Canakinumab 150 mg Drug
- Triamcinolone acetonide 40 mg Drug
- Placebo to canakinumab Drug
- Placebo to triamcinolone acetonide Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2010 (Type not available)
- Primary completion
- Nov 2010 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Jan 30, 2014
2010 – 2011
United States locations
- U.S. sites
- 96
- U.S. states
- 30
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Novartis Investigative site | Foley | Alabama | 36535 | — |
| Horizon Research Group, Inc. | Mobile | Alabama | 36608 | — |
| Sun Valley Arthritis Center, Ltd | Peoria | Arizona | 85381 | — |
| Genova Clinical Research | Tucson | Arizona | 85741 | — |
| Little Rock Diagnostic Clinic | Little Rock | Arkansas | 72205 | — |
| Providence Research | Burbank | California | 91505 | — |
| Diagnamics, Inc. | Carlsbad | California | 92008 | — |
| Med Investigations | Fair Oaks | California | 95628 | — |
| Valerius Medical Group and Research Center of Long Branch | Long Beach | California | 90806 | — |
| Lucita M. Cruz, M.D., Inc. | Norwalk | California | 90650 | — |
| Sierra Clinical Research | Orangevale | California | 95662 | — |
| Chaparral Medical Grp, INC Clinical Research | Pomona | California | 91767 | — |
| River City Clinical Research | Sacramento | California | 95816 | — |
| Arthritis Associates | San Antonio | California | 782209 | — |
| California Research Foundation | San Diego | California | 92103 | — |
| Rochester clinical Research | San Diego | California | 92108 | — |
| Ritchken and First MDs | San Diego | California | 92117 | — |
| Huntington Medical Foundation | San Marino | California | 91108 | — |
| Crest Clinical Trials | Santa Ana | California | 92701 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Progressive Clinical Research | Vista | California | 92803 | — |
| Center for Clinical Trials of San Gabriel | West Covina | California | 91790 | — |
| Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC | Danbury | Connecticut | 06810 | — |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | — |
| Health Awareness | Jupiter | Florida | 33458 | — |
| Pines Research, LLC Pembroke Clinical Trials | Pembroke Pines | Florida | 33028 | — |
| DMI Healthcare Group, Inc. | Pinellas Park | Florida | 33782 | — |
| Tampa Medical Group, P.A. | Tampa | Florida | 33614 | — |
| RST DAta Research | Conyers | Georgia | 30012 | — |
| Q Clinical Research | Decatur | Georgia | 30035 | — |
| Harbin Clinic | Rome | Georgia | 30165 | — |
| Sonora Clinical Research, LLC | Boise | Idaho | 83702 | — |
| Northwest Clinical Trials | Boise | Idaho | 83704 | — |
| The Arthritis Center | Springfield | Illinois | 62704 | — |
| Deaconess Clinic | Evansville | Indiana | 47713 | — |
| Pinnacle Medical Research | Overland Park | Kansas | 66215 | — |
| Wichita Clinic | Wichita | Kansas | 67208 | — |
| Dolby Research, LLC | Baton Rouge | Louisiana | 70809 | — |
| Gulf Coast Research, LLC | Lafayette | Louisiana | 70508 | — |
| Clinical Trials Management | Metairie | Louisiana | 70006 | — |
| Arthritis and Diabetes Clinic | Monroe | Louisiana | 71203 | — |
| Regional Research Specialists | Shreveport | Louisiana | 71106 | — |
| The Family Doctors | Shreveport | Louisiana | 71115 | — |
| Center for Rheumatology & Bone Research | Wheaton | Maryland | 20902 | — |
| MASS Research, LLC | Waltham | Massachusetts | 02453 | — |
| Clarkston Medical Group | Clarkston | Michigan | 48346 | — |
| L Kage Healthcare Services | Flint | Michigan | 48532 | — |
| West Michigan Rheumatology | Grand Rapids | Michigan | 49546 | — |
| *Private Practice* | Lansing | Michigan | 48910 | — |
| Oakland Medical Research Center | Troy | Michigan | 48085 | — |
| Arthritis Associates of Mississippi | Jackson | Mississippi | 39202 | — |
| CRC of Jackson | Jackson | Mississippi | 39202 | — |
| Phillips Medical Center | Jackson | Mississippi | 39209 | — |
| Montana Medical Research | Missoula | Montana | 59808 | — |
| Quality Clinical Research | Omaha | Nebraska | 68114 | — |
| Heartland Clinical Research, Inc. | Omaha | Nebraska | 68134 | — |
| Clinical Research Advantage, Inc | Henderson | Nevada | 89014 | — |
| Arthritis and Osteoporosis Associates | Freehold | New Jersey | 07728 | — |
| UMDNJ Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| Arthritis and Osteoporosis Medical Association | Brooklyn | New York | 11201 | — |
| Andrew J. Porges, MD, PC | Roslyn | New York | 11576 | — |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | — |
| The Center For Nutrition and Preventive Medicine | Charlotte | North Carolina | 28277 | — |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | — |
| Jones Family Practice, PA | Shelby | North Carolina | 28150 | — |
| Columbia Arthritis Center | Columbus | Ohio | 43215 | — |
| STAT Research, Inc. | Dayton | Ohio | 45417 | — |
| Ohio Clinical Research, LLC | Willoughby Hills | Ohio | 44094 | — |
| Humility of Mary Health Partners DBA St. Elizabeth Health Ce | Youngstown | Ohio | 44501 | — |
| Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Philadelphia VA medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Partners in Clinical Research | Bumberland | Rhode Island | 02864 | — |
| Medical Research South | Charleston | South Carolina | 29407 | — |
| Pharmacorp Clinical Trials, INC | Charleston | South Carolina | 29412 | — |
| Tlm Medical Services Llc | Columbia | South Carolina | 29204 | — |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29601 | — |
| Community Research Partners, Inc. | Varnville | South Carolina | 29924 | — |
| Community Research Partners, Inc. | Varnville | South Carolina | 29944 | — |
| Tri-Cities Medical Research | Bristol | Tennessee | 37620 | — |
| Alpha Clinical Research | Clarksville | Tennessee | 37403 | — |
| The Jackson Clinic | Jackson | Tennessee | 38301 | — |
| The Arthritis Clinic | Jackson | Tennessee | 38305 | — |
| MultiSpecialty Clinical Research | Johnson City | Tennessee | 37601 | — |
| Lovelace Scientific Resource | Austin | Texas | 78758 | — |
| Rheumatic Disease Clinical Research Center, Llc | Houston | Texas | 77004 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| Leander Healthcare Center | Leander | Texas | 78641 | — |
| Accurate Clinical Research | Nassau Bay | Texas | 77058 | — |
| North Hills Family Practice | North Richard Hills | Texas | 76180 | — |
| Arthritis Center South Texas | San Antonio | Texas | 78232 | — |
| Novartis Investigative site | Danville | Virginia | 24541 | — |
| Health Research of Hampton Roads | Newport News | Virginia | 23606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01080131, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2014 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01080131 live on ClinicalTrials.gov.