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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Gouty Arthritis

Intervention: Canakinumab pre-filled syringe (Drug); Canakinumab lyophilized powder (Drug); Triamcinolone Acetonide (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

Official title: A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

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

Time to the First New Gouty Arthritis Flare

Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS

Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale

Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale

Physician's Assessment of Tenderness

Physician's Assessment of Swelling

Physician's Assessment of Erythema

Physician's Assessment of Range of Motion of the Most Affected Joint

Proportion of Patients With Rescue Medication Intake

Time to First Rescue Medication Intake

Amount of Rescue Medication Taken (mg)

C-reactive Protein Level

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

- 3 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

Exclusion criteria:

- 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

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Bad Doberan 18209, Germany

Novartis Investigative Site, Bayreuth 95445, Germany

Novartis Investigative Site, Berlin 13125, Germany

Novartis Investigative Site, Loehne 32584, Germany

Novartis Investigative Site, Magdeburg 39110, Germany

Novartis Investigative Site, Messkirch 88605, Germany

Novartis Investigative Site, Regensburg 93053, Germany

Novartis Investigative Site, Weener 26826, Germany

Novartis Investigative Site, Zwiesel 94227, Germany

Novartis Investigative Site, Bekescsaba H-5600, Hungary

Novartis Investigative Site, Budapest 1023, Hungary

Novartis Investigative Site, Budapest 1027, Hungary

Novartis Investigative Site, Debrecen 4032, Hungary

Novartis Investigative Site, Eger 3300, Hungary

Novartis Investigative Site, Gyula 5703, Hungary

Novartis Investigative Site, Kistarcsa 2143, Hungary

Novartis Investigative Site, Szikszo 3800, Hungary

Novartis Investigative Site, Szolnok 5000, Hungary

Novartis Investigative Site, Veszprem H-8200, Hungary

Novartis Investigative Site, Klaipeda 92288, Lithuania

Novartis Investigative Site, Vilnius 09020, Lithuania

Novartis Investigative Site, Vilnius LT-08661, Lithuania

Novartis Investigative Site, Anniston, Alabama 36207-5710, United States

Novartis Investigative Site, Gulf Shores, Alabama 36547, United States

Novartis Investigative Site, Mobile, Alabama 36608, United States

Novartis Investigative Site, Chandler, Arizona 85224, United States

Novartis Investigative Site, Phoenix, Arizona 85013, United States

Novartis Investigative Site, Scottsdale, Arizona 85251, United States

Novartis Investigative Site, Buena Park, California 90620, United States

Novartis Investigative Site, Fair Oaks, California 95628, United States

Novartis Investigative Site, Norwalk, California 90650, United States

Novartis Investigative Site, Orangevale, California 95662, United States

Novartis Investigative Site, Pasadena, California 91105, United States

Novartis Investigative Site, Westlake Village, California 91361, United States

Novartis Investigative Site, Clearwater, Florida 33756, United States

Novartis Investigative Site, Jupiter, Florida 33458, United States

Novartis Investigative Site, Largo, Florida 33773, United States

Novartis Investigative Site, South Miami, Florida 33143, United States

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Novartis Investigative Site, Kaunas, LT 50128, Lithuania

Novartis Investigative Site, Kaunas, LT 51349, Lithuania

Novartis Investigative Site, Vilnius, LT 01117, Lithuania

Novartis Investigative Site, Metairie, Louisiana 70006, United States

Novartis Investigative Site, Troy, Michigan 48085, United States

Novartis Investigative Site, Belzoni, Mississippi 39038, United States

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Novartis Investigative Site, Missoula, Montana 59804, United States

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Novartis Investigative Site, Omaha, Nebraska 68114, United States

Novartis Investigative Site, Omaha, Nebraska 68134, United States

Novartis Investigative Site, Freehold, New Jersey 07728, United States

Novartis Investigative Site, Mineola, New York 11501, United States

Novartis Investigative Site, New Hyde Park, New York 11042, United States

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Novartis Investigative Site, St-John's, Newfoundland and Labrador A1E 2C2, Canada

Novartis Investigative Site, St. John, Newfoundland and Labrador A1B 5E8, Canada

Novartis Investigative Site, Asheville, North Carolina 28801, United States

Novartis Investigative Site, Cary, North Carolina 27518, United States

Novartis Investigative Site, Charlotte, North Carolina 28209, United States

Novartis Investigative Site, Charlotte, North Carolina 28277, United States

Novartis Investigative Site, Greensboro, North Carolina 27401, United States

Novartis Investigative Site, Greensboro, North Carolina 27408, United States

Novartis Investigative Site, Salisbury, North Carolina 28144, United States

Novartis Investigative Site, Shelby, North Carolina 28152, United States

Novartis Investigative Site, Wilmington, North Carolina 28401, United States

Novartis Investigative Site, Fargo, North Dakota 58103, United States

Novartis Investigative Site, Mogadore, Ohio 44260, United States

Novartis Investigative Site, Oklahoma City, Oklahoma 73109, United States

Novartis Investigative Site, Toronto, Ontario M9W 4L6, Canada

Novartis Investigative Site, Duncansville, Pennsylvania 16635, United States

Novartis Investigative Site, Sainte-Foy, Quebec G1v 3M7, Canada

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Novartis Investigative Site, Charleston, South Carolina 29412, United States

Novartis Investigative Site, Columbia, South Carolina 29204, United States

Novartis Investigative Site, Greer, South Carolina 29651, United States

Novartis Investigative Site, Murrells Inlet, South Carolina 29576, United States

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Novartis Investigative Site, Bristol, Tennessee 37620, United States

Novartis Investigative Site, Fayetteville, Tennessee 33734, United States

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Novartis Investigative Site, Memphis, Tennessee 38125, United States

Novartis Investigative Site, Bedford, Texas 76021, United States

Novartis Investigative Site, Dallas, Texas 75231, United States

Novartis Investigative Site, Houston, Texas 77034, United States

Novartis Investigative Site, Bountiful, Utah 84010, United States

Novartis Investigative Site, Charlottesville, Virginia 22911, United States

Novartis Investigative Site, Danville, Virginia 24541, United States

Novartis Investigative Site, Midlothian, Virginia 23114, United States

Novartis Investigative Site, Newport News, Virginia 23606, United States

Novartis Investigative Site, Bellevue, Washington 98004, United States

Additional Information

Starting date: May 2011
Last updated: December 10, 2013

Page last updated: August 23, 2015

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