Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

PHASE3CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

November 30, 2010

Study Completion Date

October 31, 2011

Conditions
Acute Gout
Interventions
DRUG

Canakinumab 150 mg

Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).

DRUG

Triamcinolone acetonide 40 mg

Triamcinolone acetonide 40 mg was supplied as a suspension.

DRUG

Placebo to canakinumab

Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.

DRUG

Placebo to triamcinolone acetonide

Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.

Trial Locations (108)

11201

Arthritis and Osteoporosis Medical Association, Brooklyn

11576

Andrew J. Porges, MD, PC, Roslyn

16635

Altoona Center for Clinical Research, Duncansville

19104

Philadelphia VA medical Center, Philadelphia

20902

Center for Rheumatology & Bone Research, Wheaton

23606

Health Research of Hampton Roads, Newport News

24541

Novartis Investigative site, Danville

28150

Jones Family Practice, PA, Shelby

28209

Metrolina Medical Research, Charlotte

28277

The Center For Nutrition and Preventive Medicine, Charlotte

28601

Unifour Medical Research Associates, Hickory

29204

Tlm Medical Services Llc, Columbia

29407

Medical Research South, Charleston

29412

Pharmacorp Clinical Trials, INC, Charleston

29601

Palmetto Clinical Trial Services, LLC, Greenville

29924

Community Research Partners, Inc., Varnville

29944

Community Research Partners, Inc., Varnville

30012

RST DAta Research, Conyers

30035

Q Clinical Research, Decatur

30165

Harbin Clinic, Rome

33028

Pines Research, LLC Pembroke Clinical Trials, Pembroke Pines

33458

Health Awareness, Jupiter

33614

Tampa Medical Group, P.A., Tampa

33756

Innovative Research of West Florida, Clearwater

33782

DMI Healthcare Group, Inc., Pinellas Park

35294

University of Alabama at Birmingham, Birmingham

36207

Pinnacle Research Group, LLC, Anniston

36535

Novartis Investigative site, Foley

36608

Horizon Research Group, Inc., Mobile

37403

Alpha Clinical Research, Clarksville

37601

MultiSpecialty Clinical Research, Johnson City

37620

Tri-Cities Medical Research, Bristol

38301

The Jackson Clinic, Jackson

38305

The Arthritis Clinic, Jackson

39202

Arthritis Associates of Mississippi, Jackson

CRC of Jackson, Jackson

39209

Phillips Medical Center, Jackson

43215

Columbia Arthritis Center, Columbus

44094

Ohio Clinical Research, LLC, Willoughby Hills

44501

Humility of Mary Health Partners DBA St. Elizabeth Health Ce, Youngstown

45417

STAT Research, Inc., Dayton

47713

Deaconess Clinic, Evansville

48085

Oakland Medical Research Center, Troy

48346

Clarkston Medical Group, Clarkston

48532

L Kage Healthcare Services, Flint

48910

*Private Practice*, Lansing

49546

West Michigan Rheumatology, Grand Rapids

59808

Montana Medical Research, Missoula

62704

The Arthritis Center, Springfield

66215

Pinnacle Medical Research, Overland Park

67208

Wichita Clinic, Wichita

68114

Quality Clinical Research, Omaha

68134

Heartland Clinical Research, Inc., Omaha

70006

Clinical Trials Management, Metairie

70508

Gulf Coast Research, LLC, Lafayette

70809

Dolby Research, LLC, Baton Rouge

71106

Regional Research Specialists, Shreveport

71115

The Family Doctors, Shreveport

71203

Arthritis and Diabetes Clinic, Monroe

72205

Little Rock Diagnostic Clinic, Little Rock

73103

Health Research of Oklahoma, PLLC, Oklahoma City

73109

Health Research Institute, Oklahoma City

76180

North Hills Family Practice, North Richard Hills

77004

Rheumatic Disease Clinical Research Center, Llc, Houston

77058

Accurate Clinical Research, Nassau Bay

77566

R/D Clinical Research, Inc., Lake Jackson

78232

Arthritis Center South Texas, San Antonio

78641

Leander Healthcare Center, Leander

78758

Lovelace Scientific Resource, Austin

83702

Sonora Clinical Research, LLC, Boise

83704

Northwest Clinical Trials, Boise

85381

Sun Valley Arthritis Center, Ltd, Peoria

85741

Genova Clinical Research, Tucson

89014

Clinical Research Advantage, Inc, Henderson

90650

Lucita M. Cruz, M.D., Inc., Norwalk

90806

Valerius Medical Group and Research Center of Long Branch, Long Beach

91108

Huntington Medical Foundation, San Marino

91505

Providence Research, Burbank

91767

Chaparral Medical Grp, INC Clinical Research, Pomona

91790

Center for Clinical Trials of San Gabriel, West Covina

92008

Diagnamics, Inc., Carlsbad

92103

California Research Foundation, San Diego

92108

Rochester clinical Research, San Diego

92117

Ritchken and First MDs, San Diego

92701

Crest Clinical Trials, Santa Ana

92780

Orange County Research Center, Tustin

92803

Progressive Clinical Research, Vista

95628

Med Investigations, Fair Oaks

95662

Sierra Clinical Research, Orangevale

95816

River City Clinical Research, Sacramento

782209

Arthritis Associates, San Antonio

06810

Clinical Res Ct of CT - Arthritis Associates of CT/NY, LLC, Danbury

02453

MASS Research, LLC, Waltham

07728

Arthritis and Osteoporosis Associates, Freehold

08903

UMDNJ Robert Wood Johnson Medical School, New Brunswick

02864

Partners in Clinical Research, Bumberland

Unknown

Novartis Investigative Site, Vancouver

Novartis Investigative Site, St. John's

Novartis Investigative site, Sainte-Foy

Novartis Investigative Site, Kaohsiung Hsien

Novartis Investigative Site, Kaohsiung

Novartis Investigative Site, Taichung

Novartis Investigative Site, Taipei

Novartis Investigative Site, Enschede

Novartis Investigative site, Leeuwarden

Novartis Investigative Site, Moscow

Novartis Investigative Site, Yaroslavl

Novartis Investigative Site, Yekaterinburg

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY