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A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

Primary Purpose

Gout

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Canakinumab

Colchicine

Allopurinol

Placebo Matching Canakinumab

Placebo Matching Colchicine

About this trial

This is an interventional prevention trial for Gout focused on measuring Gout, Chronic gout, Gouty arthritis, Gout flares

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Core study

Inclusion Criteria:

Signed written informed consent before any study procedure is performed.
History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy.
Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout.
Body Mass Index (BMI) ≤ 40 kg/m^2.
Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy.

Exclusion Criteria:

Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period.
History of allergy or contraindication to colchicine or allopurinol.
History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use.
History of bone marrow suppression.
Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone.

Extension study

Inclusion criteria:

Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion Criteria:

Patients for whom continuation in the extension study is not considered appropriate by the treating physician.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).

Other protocol-defined inclusion/exclusion criteria applied to the study.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Core study: Canakinumab 25 mg

Core study: Canakinumab 50 mg

Core study: Canakinumab 100 mg

Core study: Canakinumab 200 mg

Core study: Canakinumab 300 mg

Core study: Canakinumab q4wk

Core study: Colchicine 0.5 mg

Extension study: Group A

Extension study: Group B

Extension study: Group C

Extension study: Group D

Arm Description

Canakinumab 25 mg subcutaneously (sc) once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Canakinumab 50 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Canakinumab 100 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Canakinumab 300 mg sc once at Day 1, placebo sc at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Canakinumab 50 mg sc at Days 1, and 29 followed by canakinumab 25 mg sc on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.

Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.

Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.

Outcomes

Primary Outcome Measures

Core Study: Mean Number of Gout Flares Per Participant

A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Secondary Outcome Measures

Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab

Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization

The percentage of participants experiencing at least 1 gout flare within 16 weeks after randomization. A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Core Study: Percentage of Participants With Gout Flare at Different Time Points

A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares

Participants rated the intensity of pain in the most affected joint on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.

Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares

Participants assessed the intensity of pain in the most affected joint on a 5-point Likert scale, which ranged from 1 to 5 (1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Extreme). Participants assessed pain intensity on the day of onset of the gout flare and in the morning of the 6 following days.

Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale

The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at Days 15, 29, 57, 85, 113, and 141. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.

Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare

Participant's rated the intensity of pain in the most affected joint during the first flare on a 0-100 mm visual analog scale, which ranged from no pain (left end, 0) to unbearable pain (right end, 100). Assessments were made pre-dose and 24 hours, 3 days, 4 days, and an average of 5-7 days post-dose

Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale

Study participants made a global assessment of their response to treatment on a 5-point Likert scale (Excellent, Good, Acceptable, Slight, Poor) at the control visit 7±2 days following each of their first 3 flares. The number of participants in each of the 5 categories of the Likert scale are reported.

Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale

The study physician made a global assessment of the participant's response to treatment on a 5-point Likert scale (Very good, Good, Fair, Poor, Very poor) at the control visit 7±2 days following each of the first 3 flares. The category 'Not assessed' includes missing data and 'not done'. The number of participants in each of the 5 categories of the Likert scale are reported.

Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare

Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.

Extension Study: Amount of Rescue Medication Taken

The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.

Full Information

NCT ID

NCT00819585

First Posted

January 8, 2009

Last Updated

June 19, 2018

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00819585

Brief Title

A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

Official Title

A 24-week, Dose-ranging, Multicenter, Double-blind, Double-dummy, Active-controlled Core Study to Evaluate Canakinumab for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy and a 24-week Open-label, Multicenter Extension Study to Assess Safety, Tolerability and Efficacy of Canakinumab in Patients With Gout Who Are Given Canakinumab at the Time of Gout Flare

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. The core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gout

Keywords

Gout, Chronic gout, Gouty arthritis, Gout flares

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

432 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Core study: Canakinumab 25 mg

Arm Type

Experimental

Arm Description

Arm Title

Core study: Canakinumab 50 mg

Arm Type

Experimental

Arm Description

Arm Title

Core study: Canakinumab 100 mg

Arm Type

Experimental

Arm Description

Arm Title

Core study: Canakinumab 200 mg

Arm Type

Experimental

Arm Description

Arm Title

Core study: Canakinumab 300 mg

Arm Type

Experimental

Arm Description

Arm Title

Core study: Canakinumab q4wk

Arm Type

Experimental

Arm Description

Arm Title

Core study: Colchicine 0.5 mg

Arm Type

Active Comparator

Arm Description

Arm Title

Extension study: Group A

Arm Type

Experimental

Arm Description

Participants who were randomized to canakinumab in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Arm Title

Extension study: Group B

Arm Type

Experimental

Arm Description

Patients who were randomized to canakinumab in the core study but did not receive treatment with canakinumab in the extension study.

Arm Title

Extension study: Group C

Arm Type

Experimental

Arm Description

Patients who were randomized to colchicine in the core study and were treated with canakinumab for at least 1 flare in the extension study.

Arm Title

Extension study: Group D

Arm Type

Experimental

Arm Description

Patients who were randomized to colchicine in the core study but did not receive treatment with canakinumab in the extension study.

Intervention Type

Drug

Intervention Name(s)

Canakinumab

Intervention Description

Canakinumab was supplied in glass vials as a lyophilized powder.

Intervention Type

Drug

Intervention Name(s)

Colchicine

Intervention Description

0.5 mg capsule orally once daily for 16 weeks.

Intervention Type

Drug

Intervention Name(s)

Allopurinol

Intervention Description

100-300 mg orally once daily for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo Matching Canakinumab

Intervention Description

Subcutaneous injection.

Intervention Type

Drug

Intervention Name(s)

Placebo Matching Colchicine

Intervention Description

Capsule orally once daily for 16 weeks.

Primary Outcome Measure Information:

Title

Core Study: Mean Number of Gout Flares Per Participant

Description

A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Time Frame

Baseline of the core study to Week 16

Secondary Outcome Measure Information:

Title

Core Study: Mean Number of Gout Flares for the Repeat Dose Regimen of Canakinumab as Compared to the Single Doses of Canakinumab

Time Frame

up to 16 weeks after randomization

Title

Core Study: Percentage of Participants With at Least 1 Gout Flare Within 16 Weeks After Randomization

Description

Time Frame

Baseline of the core study to Week 16

Title

Core Study: Percentage of Participants With Gout Flare at Different Time Points

Description

A gout flare was defined as an increase in participant-reported gout pain in the most affected joint during a gout attack.

Time Frame

Days 2, 4, 6, and Weeks 2, 4, 6, 10, and 16 of the core study

Title

Core Study: Participant's Assessment of Gout Pain on a 0-100 mm Visual Analog Scale up to Day 7 of All Gout Flares

Description

Time Frame

Baseline of the core study to Week 16

Title

Core Study: Participant's Assessment of Gout Pain on a 5-point Likert Scale up to Day 7 of All Gout Flares

Description

Time Frame

Baseline of the core study to Week 16

Title

Core Study: Physician's Global Assessment of Response to Therapy on a 5-point Likert Scale

Description

Time Frame

Days 15, 29, 57, 85, 113, and 141 of the core study

Title

Extension Study: Participant's Assessment of Gout Pain on a 100 mm Visual Analog Scale During the First Flare

Description

Time Frame

Baseline of the extension study until 7 days after the onset of the first gout flare (up to 24 weeks)

Title

Extension Study: Participant's Global Assessment of Response to Treatment on a 5-point Likert Scale

Description

Time Frame

Baseline of the extension study until the end of the study (up to 24 weeks)

Title

Extension Study: Physician's Global Assessment of Response to Treatment on a 5-point Likert Scale

Description

Time Frame

Baseline of the extension study until the end of the study (up to 24 weeks)

Title

Extension Study: Physician's Assessment of Tenderness, Swelling, and Erythema in the Most Affected Joint During the First Flare

Description

Time Frame

Baseline of the extension study until the end of the study (up to 24 weeks)

Title

Extension Study: Amount of Rescue Medication Taken

Description

The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.

Time Frame

Baseline of the extension study until the end of the study (up to 24 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Core study Inclusion Criteria: Signed written informed consent before any study procedure is performed. History of at least 2 gout flares in the year prior to Screening (Visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy. Confirmed diagnosis of gout meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of arthritis of primary gout. Body Mass Index (BMI) ≤ 40 kg/m^2. Willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before Screening (Visit 1) or willing to re-initiate allopurinol therapy if this was stopped > 2 months before Screening (Visit 1) for reasons different to toxicity/ intolerance or lack of efficacy. Exclusion Criteria: Acute gout flare within 2 weeks of Screening (Visit 1) and during the Screening period. History of allergy or contraindication to colchicine or allopurinol. History of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use. History of bone marrow suppression. Absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone. Extension study Inclusion criteria: Patients who completed the core study. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9). Patients who have signed a written informed consent before any trial procedure is performed. Exclusion Criteria: Patients for whom continuation in the extension study is not considered appropriate by the treating physician. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine). Other protocol-defined inclusion/exclusion criteria applied to the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Talbert Medical Group

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

San Diego Arthritis & Osteoporosis Medical clinic

City

San Diego

State/Province

California

Country

United States

Facility Name

Health Awareness

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

East-West Medical Research institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Pinnacle Medical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Cotton O'Neil Clinical Research Institute

City

Topeka

State/Province

Kansas

Country

United States

Facility Name

Dolby Research, LLC

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

The Family Doctors

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71115

Country

United States

Facility Name

Shores Rheumatology

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Heartland Clinical Research, Inc.

City

Omaha

State/Province

Nebraska

Country

United States

Facility Name

NM Clinical Research & Osteoporosis Ct.

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Rochester clinical Research

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Health Research of Oklahoma, PLLC

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Castlerock Clinical Research Consultants, LLC

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Columbia Clinical Research

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

Upstate Pharmaceutical Research

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

MultiSpecialty Clinical Research

City

Johnson City

State/Province

Tennessee

Country

United States

Facility Name

iMED Internal medicine, PA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78228

Country

United States

Facility Name

Novartis Investigative site

City

Buenos Aires

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

Country

Argentina

Facility Name

Novartis Investigative site

City

Rosario

Country

Argentina

Facility Name

Novartis Investigative Site

City

Gozée

Country

Belgium

Facility Name

Novartis Investigative site

City

Oostham

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bacaramanga

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

Country

Colombia

Facility Name

Fundación Cardiovascular de Colombia

City

Florida Blanca

Country

Colombia

Facility Name

Novartis Investigative site

City

Havirov

Country

Czechia

Facility Name

Novartis Investigative site

City

Ostrava

Country

Czechia

Facility Name

Novartis Investigative site

City

Pardubice

Country

Czechia

Facility Name

Novartis Investigative site

City

Uherske Hradiste

Country

Czechia

Facility Name

Novartis Investigative site

City

Zlin

Country

Czechia

Facility Name

Novartis Investigative Site

City

Bautzen

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

Country

Germany

Facility Name

Novartis Investigative Site

City

Georgensgmuend

Country

Germany

Facility Name

Novartis Investigative Site

City

Goettingen

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Messkirch

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

Country

Germany

Facility Name

Novartis Investigative Site

City

Riedlhuette

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwabach

Country

Germany

Facility Name

Novartis Investigative site

City

Guatemala City

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Debrecen

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kistarcsa

Country

Hungary

Facility Name

Novartis Investigative Site

City

Zalaegerszeg

Country

Hungary

Facility Name

Novartis Investigative Site

City

Poznan

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

Country

Poland

Facility Name

Novartis Investigative site

City

Coimbra

Country

Portugal

Facility Name

Novartis Investigative site

City

Lisboa

Country

Portugal

Facility Name

Novartis Investigative site

City

Ponte de Lima

Country

Portugal

Facility Name

Novartis Investigative Site

City

Chelyabinsk

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Novartis Investigative site

City

Moscow

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

Country

Russian Federation

Facility Name

Novartis Investigative site

City

Singapore

Country

Singapore

Facility Name

Novartis Investigative Site

City

Banska Bystrica

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Nove Zamky

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Piestany

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Povazska Bystrica

Country

Slovakia

Facility Name

Novartis Investigative site

City

Trebisova

Country

Slovakia

Facility Name

Novartis Investigative site

City

Cape Town

Country

South Africa

Facility Name

Novartis Investigative site

City

Panorama

Country

South Africa

Facility Name

Novartis Investigative site

City

Port Elizabeth

Country

South Africa

Facility Name

Novartis Investigative Site

City

Barakaldo

Country

Spain

Facility Name

Novartis Investigative site

City

Madrid

Country

Spain

Facility Name

Novartis Investigative site

City

Merida

Country

Spain

Facility Name

Novartis Investigative site

City

Valencia

Country

Spain

Facility Name

Novartis Investigative site

City

Kaohsiung

Country

Taiwan

Facility Name

Novartis Investigative site

City

Taichung

Country

Taiwan

Facility Name

Novartis Investigative site

City

Taipei

Country

Taiwan

Facility Name

Baskent University Medical Faculty

City

Adana

Country

Turkey

Facility Name

Baskent University Medical Faculty

City

Ankara

Country

Turkey

Facility Name

Adnan Menderes University Medical Faculty

City

Aydin

Country

Turkey

Facility Name

Cukurova University Medical Faculty

City

Balcali Adana

Country

Turkey

Facility Name

Pamukkale University medical Faculty

City

Denizli Kampus

Country

Turkey

Facility Name

Gaziantep University Medical Faculty

City

Gaziantep

Country

Turkey

Facility Name

Dokuz Eylul University Medical Faculty

City

Izmir

Country

Turkey

Facility Name

Celal Bayar University Medical Faculty

City

Manisa

Country

Turkey

Facility Name

Gables Medicentre

City

Coventry

Country

United Kingdom

Facility Name

Flyde Coast Clinical Research Ltd

City

Lancashire

Country

United Kingdom

12. IPD Sharing Statement

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A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)

Gout

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial