Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

NCT01356602 | Completed Phase 3 Results

• 2 other identifiers: CACZ885H23612010-024173-39
• Study Type: interventional
• Target: 397
• Locations: 5 countries
• Sites: 99

Brief Summary

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.

Conditions

Acute Gouty Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups

  The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.

  72 hours post dose

Secondary Outcomes (17)

• Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups

  72 hours post dose

• Patient's Assessment of Pain Intensity on a 0-100mm VAS

  14 days

• Patient's Assessment of Pain Intensity on a 5-point Likert Scale

  72 hours

• Number of Patients With at Least One New Gouty Arthritis Flare After Baseline

  12 weeks

• Time to the First New Gouty Arthritis Flare

  12 weeks

Study Arms (3)

Canakinumab, pre-filled syringes (PFS)

EXPERIMENTAL

Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.

Drug: Canakinumab pre-filled syringe; Drug: Placebo

Canakinumab, lyophilizate (LYO)

ACTIVE COMPARATOR

The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.

Drug: Canakinumab lyophilized powder; Drug: Placebo

Triamcinolone Acetonide

ACTIVE COMPARATOR

The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

Drug: Triamcinolone Acetonide; Drug: Placebo

Interventions

Canakinumab pre-filled syringe DRUG

Canakinumab pre-filled syringe

Canakinumab, pre-filled syringes (PFS)

Canakinumab lyophilized powder DRUG

Canakinumab lyophilized powder

Canakinumab, lyophilizate (LYO)

Triamcinolone Acetonide DRUG

Triamcinolone Acetonide

Triamcinolone Acetonide

Placebo DRUG

Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Canakinumab, lyophilizate (LYO); Canakinumab, pre-filled syringes (PFS); Triamcinolone Acetonide

Eligibility Criteria

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

You may qualify if:

• or more gout flares within last year
• Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine
• Body mass index of less than or equal to 45 kg/m2

You may not qualify if:

• Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine.
• Hemodialysis
• Live vaccine within 3 months before first dose
• Donation or loss of 400 mL or more within 3 months before first dose
• Gout brought on by other factors such as chemotherapy, lead, transplant, etc.
• Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis
• Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions
• Significant cardiovascular conditions such as uncontrolled hypertension
• Significant medical diseases such as uncontrolled diabetes, thyroid disease
• History of malignancy of any organ system within the past 5 years
• Women who are pregnant or nursing

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (99)

Novartis Investigative Site

Anniston, Alabama, 36207-5710, United States

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Novartis Investigative Site

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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Phoenix, Arizona, 85013, 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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Fair Oaks, California, 95628, United States

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Norwalk, California, 90650, United States

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Orangevale, California, 95662, United States

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Pasadena, California, 91105, United States

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Westlake Village, California, 91361, United States

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Clearwater, Florida, 33756, 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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Meridian, Idaho, 83642, United States

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Overland Park, Kansas, 66215, 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, 39202, 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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Freehold, New Jersey, 07728, 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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Charlotte, North Carolina, 28277, United States

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Greensboro, North Carolina, 27401, United States

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Greensboro, North Carolina, 27408, 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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Oklahoma City, Oklahoma, 73109, 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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Greer, South Carolina, 29651, United States

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Murrells Inlet, South Carolina, 29576, United States

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Ninety Six, South Carolina, 29666, 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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Fayetteville, Tennessee, 33734, 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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Houston, Texas, 77034, United States

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Bountiful, Utah, 84010, United States

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Charlottesville, Virginia, 22911, 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, 98004, United States

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St. John's, Newfoundland and Labrador, A1B 5E8, Canada

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

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Toronto, Ontario, M9W 4L6, Canada

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Sainte-Foy, Quebec, G1v 3M7, Canada

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Saskatoon, Saskatchewan, S7K 0H6, Canada

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Bad Doberan, 18209, Germany

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Bayreuth, 95445, Germany

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Berlin, 13125, Germany

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Löhne, 32584, Germany

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Magdeburg, 39110, Germany

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Messkirch, 88605, Germany

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Regensburg, 93053, Germany

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Novartis Investigative Site

Weener, 26826, Germany

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Zwiesel, 94227, Germany

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Szikszó, Hungary, 3800, Hungary

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Békéscsaba, H-5600, Hungary

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Budapest, 1023, Hungary

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Budapest, 1027, Hungary

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Debrecen, 4032, Hungary

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Eger, 3300, Hungary

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Gyula, 5703, Hungary

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Kistarcsa, 2143, Hungary

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Szolnok, 5000, Hungary

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Veszprém, H-8200, Hungary

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Kaunas, LT, 50128, Lithuania

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Kaunas, LT, 51349, Lithuania

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Vilnius, LT, 01117, Lithuania

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Novartis Investigative Site

Klaipėda, 92288, Lithuania

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Novartis Investigative Site

Vilnius, 09020, Lithuania

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Novartis Investigative Site

Vilnius, LT-08661, Lithuania

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MeSH Terms

Conditions

Gout; Arthritis; Rheumatic Diseases

Interventions

Triamcinolone Acetonide

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 19, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 29, 2014
• Results First Posted: January 29, 2014

Record last verified: 2013-12

Locations

CA (5); LI (6); HU (10); US (69); DE (9)