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Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

NCT ID: NCT01431638

Last Updated: 2021-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-25

Study Completion Date

2013-05-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Gouty Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Uncontrolled
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canakinumab 150mg

Canakinumab 150mg in prefilled syringe subcutaneously

Group Type EXPERIMENTAL

Canakinumab 150mg in prefilled syringe

Intervention Type DRUG

Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Interventions

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Canakinumab 150mg in prefilled syringe

Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Compliance and completion of the canakinumab PFS core study
* Unchanged significant clinical medical history from entry into core study

Exclusion Criteria

* Physician judgment of unsuitability for the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Anniston, Alabama, United States

Site Status

Novartis Investigative Site

Gulf Shores, Alabama, United States

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Mobile, Alabama, United States

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Chandler, Arizona, United States

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Scottsdale, Arizona, United States

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Buena Park, California, United States

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Norwalk, California, United States

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Westlake Village, California, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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South Miami, Florida, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Owensboro, Kentucky, United States

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Metairie, Louisiana, United States

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Troy, Michigan, United States

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Belzoni, Mississippi, United States

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Jackson, Mississippi, United States

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Picayune, Mississippi, United States

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Missoula, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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Roslyn, New York, United States

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Asheville, North Carolina, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Salisbury, North Carolina, United States

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Shelby, North Carolina, United States

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Wilmington, North Carolina, United States

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Fargo, North Dakota, United States

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Mogadore, Ohio, United States

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Duncansville, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Fort Mill, South Carolina, United States

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Greer, South Carolina, United States

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Varnville, South Carolina, United States

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Bedford, Texas, United States

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Dallas, Texas, United States

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League City, Texas, United States

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Bountiful, Utah, United States

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Danville, Virginia, United States

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Midlothian, Virginia, United States

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Newport News, Virginia, United States

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Bellevue, Washington, United States

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Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

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Novartis Investigative Site

St. John's, Newfoundland and Labrador, Canada

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Novartis Investigative Site

Sainte-Foy, Quebec, Canada

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Novartis Investigative Site

Regensburg, Bavaria, Germany

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Novartis Investigative Site

Berlin, , Germany

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Löhne, , Germany

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Magdeburg, , Germany

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Novartis Investigative Site

Weener, , Germany

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Novartis Investigative Site

Kaunas, LT, Lithuania

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Novartis Investigative Site

Kaunas, LT, Lithuania

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Novartis Investigative Site

Vilnius, LT, Lithuania

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Novartis Investigative Site

Klaipėda, , Lithuania

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Novartis Investigative Site

Vilnius, , Lithuania

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Novartis Investigative Site

Vilnius, , Lithuania

Site Status

Countries

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United States Canada Germany Lithuania

Other Identifiers

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2011-001342-15

Identifier Type: -

Identifier Source: secondary_id

CACZ885H2361E1

Identifier Type: -

Identifier Source: org_study_id

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