Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Public ClinicalTrials.gov record NCT01431638. 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 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01431638
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 397 participants
Conditions and interventions
Conditions
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
- Aug 25, 2011 (Actual)
- Primary completion
- May 9, 2013 (Actual)
- Completion
- May 9, 2013 (Actual)
- Last update posted
- Jul 19, 2021
2011 – 2013
United States locations
- U.S. sites
- 54
- U.S. states
- 23
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Anniston | Alabama | 36207-5710 | — |
| Novartis Investigative Site | Gulf Shores | Alabama | 36547 | — |
| Novartis Investigative Site | Mobile | Alabama | 36608 | — |
| Novartis Investigative Site | Chandler | Arizona | 85224 | — |
| Novartis Investigative Site | Scottsdale | Arizona | 85251 | — |
| Novartis Investigative Site | Buena Park | California | 90620 | — |
| Novartis Investigative Site | Norwalk | California | 90650 | — |
| Novartis Investigative Site | Westlake Village | California | 91361 | — |
| Novartis Investigative Site | Jupiter | Florida | 33458 | — |
| Novartis Investigative Site | Largo | Florida | 33773 | — |
| Novartis Investigative Site | South Miami | Florida | 33143 | — |
| Novartis Investigative Site | Augusta | Georgia | 30904 | — |
| Novartis Investigative Site | Decatur | Georgia | 30035 | — |
| Novartis Investigative Site | Topeka | Kansas | 66606 | — |
| Novartis Investigative Site | Louisville | Kentucky | 40217 | — |
| Novartis Investigative Site | Owensboro | Kentucky | 42303 | — |
| Novartis Investigative Site | Metairie | Louisiana | 70006 | — |
| Novartis Investigative Site | Troy | Michigan | 48085 | — |
| Novartis Investigative Site | Belzoni | Mississippi | 39038 | — |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | — |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | — |
| Novartis Investigative Site | Missoula | Montana | 59804 | — |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | — |
| Novartis Investigative Site | Mineola | New York | 11501 | — |
| Novartis Investigative Site | New Hyde Park | New York | 11042 | — |
| Novartis Investigative Site | Roslyn | New York | 11576 | — |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | — |
| Novartis Investigative Site | Cary | North Carolina | 27518 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28209 | — |
| Novartis Investigative Site | Greensboro | North Carolina | 27401 | — |
| Novartis Investigative Site | Salisbury | North Carolina | 28144 | — |
| Novartis Investigative Site | Shelby | North Carolina | 28152 | — |
| Novartis Investigative Site | Wilmington | North Carolina | 28401 | — |
| Novartis Investigative Site | Fargo | North Dakota | 58103 | — |
| Novartis Investigative Site | Mogadore | Ohio | 44260 | — |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29412 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29204 | — |
| Novartis Investigative Site | Fort Mill | South Carolina | 29707 | — |
| Novartis Investigative Site | Greer | South Carolina | 29651 | — |
| Novartis Investigative Site | Varnville | South Carolina | 29944 | — |
| Novartis Investigative Site | Bristol | Tennessee | 37620 | — |
| Novartis Investigative Site | Johnson City | Tennessee | 37601 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38125 | — |
| Novartis Investigative Site | Bedford | Texas | 76021 | — |
| Novartis Investigative Site | Dallas | Texas | 75231 | — |
| Novartis Investigative Site | League City | Texas | 77573 | — |
| Novartis Investigative Site | Bountiful | Utah | 84010 | — |
| Novartis Investigative Site | Danville | Virginia | 24541 | — |
| Novartis Investigative Site | Midlothian | Virginia | 23114 | — |
| Novartis Investigative Site | Newport News | Virginia | 23606 | — |
| Novartis Investigative Site | Bellevue | Washington | 98007 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01431638, 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 Jul 19, 2021 · Synced Oct 24, 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 NCT01431638 live on ClinicalTrials.gov.