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

NCT01431638 | Completed Phase 3 Results DMC

• 2 other identifiers: CACZ885H2361E12011-001342-15
• Study Type: interventional
• Target: 397
• Locations: 4 countries
• Sites: 68

Brief Summary

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.

Conditions

Acute Gouty Arthritis

Keywords

Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid; podagra

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Reported Adverse Events

  From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Secondary Outcomes (7)

• Probability of New Gout Flares at End of Study

  Up to Day 337

• Number of Participant With New Flares

  up to 36 weeks

• Change From Baseline in Pain Intensity on a 5-point Likert Scale

  Baseline, upto 14 days post-dose

• Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time

  Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose

• Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment

  48 weeks post-dose

Study Arms (1)

Canakinumab 150mg

EXPERIMENTAL

Canakinumab 150mg in prefilled syringe subcutaneously

Drug: Canakinumab 150mg in prefilled syringe

Interventions

Canakinumab 150mg in prefilled syringe DRUG

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

Canakinumab 150mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Physician judgment of unsuitability for the study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (68)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

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Gulf Shores, Alabama, 36547, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Scottsdale, Arizona, 85251, United States

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Buena Park, California, 90620, United States

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Norwalk, California, 90650, United States

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Westlake Village, California, 91361, United States

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Jupiter, Florida, 33458, United States

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Largo, Florida, 33773, United States

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South Miami, Florida, 33143, United States

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Augusta, Georgia, 30904, United States

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Decatur, Georgia, 30035, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40217, United States

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Owensboro, Kentucky, 42303, United States

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Metairie, Louisiana, 70006, United States

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Troy, Michigan, 48085, United States

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Belzoni, Mississippi, 39038, United States

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Jackson, Mississippi, 39209, United States

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Picayune, Mississippi, 39466, United States

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Missoula, Montana, 59804, United States

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Lincoln, Nebraska, 68516, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68134, United States

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Mineola, New York, 11501, United States

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New Hyde Park, New York, 11042, United States

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Roslyn, New York, 11576, United States

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Asheville, North Carolina, 28801, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Greensboro, North Carolina, 27401, United States

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Salisbury, North Carolina, 28144, United States

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Shelby, North Carolina, 28152, United States

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Wilmington, North Carolina, 28401, United States

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Fargo, North Dakota, 58103, United States

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Mogadore, Ohio, 44260, United States

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Duncansville, Pennsylvania, 16635, United States

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Charleston, South Carolina, 29412, United States

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Columbia, South Carolina, 29204, United States

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Fort Mill, South Carolina, 29707, United States

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Greer, South Carolina, 29651, United States

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Varnville, South Carolina, 29944, United States

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Bristol, Tennessee, 37620, United States

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Johnson City, Tennessee, 37601, United States

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Memphis, Tennessee, 38125, United States

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Bedford, Texas, 76021, United States

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Dallas, Texas, 75231, United States

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League City, Texas, 77573, United States

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Bountiful, Utah, 84010, United States

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Danville, Virginia, 24541, United States

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Midlothian, Virginia, 23114, United States

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Newport News, Virginia, 23606, United States

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Bellevue, Washington, 98007, United States

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St. John's, Newfoundland and Labrador, A1A 5E8, Canada

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St. John's, Newfoundland and Labrador, A1E 2C2, Canada

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Sainte-Foy, Quebec, G1V 3M7, Canada

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Regensburg, Bavaria, 93053, Germany

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Berlin, 10117, Germany

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Löhne, 32584, Germany

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Magdeburg, 39110, Germany

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Weener, 26826, Germany

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Kaunas, LT, 51349, Lithuania

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Kaunas, LT, LT-50128, Lithuania

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Vilnius, LT, 01117, Lithuania

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Klaipėda, LT-92288, Lithuania

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Novartis Investigative Site

Vilnius, 09310, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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MeSH Terms

Conditions

Gout; Arthritis; Rheumatic Diseases

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Uncontrolled

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 9, 2011
• Study Start: August 25, 2011
• Primary Completion: May 9, 2013
• Study Completion: May 9, 2013
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-06

Locations

LI (6); DE (5); US (54); CA (3)