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

Primary Purpose

Acute Gouty Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Canakinumab pre-filled syringe

Canakinumab lyophilized powder

Triamcinolone Acetonide

Placebo

About this trial

This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Canakinumab, pre-filled syringes (PFS)

Canakinumab, lyophilizate (LYO)

Triamcinolone Acetonide

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.

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

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.

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

Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.

Time to the First New Gouty Arthritis Flare

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

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. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.

Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.

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

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.

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

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).

Physician's Assessment of Tenderness

The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 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 affected study joint.

Physician's Assessment of Swelling

The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.

Physician's Assessment of Erythema

The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.

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

The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).

Proportion of Patients With Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time to First Rescue Medication Intake

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Amount of Rescue Medication Taken (mg)

Patients used a diary to record the time of intake of rescue medication and the amount taken.

C-reactive Protein Level

A central laboratory was used for analysis of all blood samples collected.

Full Information

NCT ID

NCT01356602

First Posted

May 16, 2011

Last Updated

December 10, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01356602

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

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

Acute Gouty Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

397 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab, pre-filled syringes (PFS)

Arm Type

Experimental

Arm Description

Arm Title

Canakinumab, lyophilizate (LYO)

Arm Type

Active Comparator

Arm Description

Arm Title

Triamcinolone Acetonide

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Canakinumab pre-filled syringe

Intervention Description

Canakinumab pre-filled syringe

Intervention Type

Drug

Intervention Name(s)

Canakinumab lyophilized powder

Intervention Description

Canakinumab lyophilized powder

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide

Intervention Description

Triamcinolone Acetonide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

72 hours post dose

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

72 hours post dose

Title

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

Description

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. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.

Time Frame

14 days

Title

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

Description

Time Frame

72 hours

Title

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

Description

Time Frame

12 weeks

Title

Time to the First New Gouty Arthritis Flare

Description

Time Frame

12 weeks

Title

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

Description

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. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.

Time Frame

14 days

Title

Time to Resolution of Gouty Arthritis Flare as Reported by Patient

Description

Time Frame

14 days

Title

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

Description

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.

Time Frame

72 hours

Title

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

Description

A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).

Time Frame

72 hours

Title

Physician's Assessment of Tenderness

Description

Time Frame

72 hours

Title

Physician's Assessment of Swelling

Description

Time Frame

72 hours

Title

Physician's Assessment of Erythema

Description

The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.

Time Frame

72 hours

Title

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

Description

Time Frame

72 hours

Title

Proportion of Patients With Rescue Medication Intake

Description

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time Frame

12 weeks

Title

Time to First Rescue Medication Intake

Description

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time Frame

14 days

Title

Amount of Rescue Medication Taken (mg)

Description

Patients used a diary to record the time of intake of rescue medication and the amount taken.

Time Frame

14 days

Title

C-reactive Protein Level

Description

A central laboratory was used for analysis of all blood samples collected.

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

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

Novartis Investigative Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207-5710

Country

United States

Facility Name

Novartis Investigative Site

City

Gulf Shores

State/Province

Alabama

ZIP/Postal Code

36547

Country

United States

Facility Name

Novartis Investigative Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Novartis Investigative Site

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Novartis Investigative Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Novartis Investigative Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85251

Country

United States

Facility Name

Novartis Investigative Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

Novartis Investigative Site

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

Novartis Investigative Site

City

Norwalk

State/Province

California

ZIP/Postal Code

90650

Country

United States

Facility Name

Novartis Investigative Site

City

Orangevale

State/Province

California

ZIP/Postal Code

95662

Country

United States

Facility Name

Novartis Investigative Site

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Novartis Investigative Site

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

Facility Name

Novartis Investigative Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Novartis Investigative Site

City

Jupiter

State/Province

Florida

ZIP/Postal Code

33458

Country

United States

Facility Name

Novartis Investigative Site

City

Largo

State/Province

Florida

ZIP/Postal Code

33773

Country

United States

Facility Name

Novartis Investigative Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Novartis Investigative Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

Facility Name

Novartis Investigative Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30035

Country

United States

Facility Name

Novartis Investigative Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Novartis Investigative Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Novartis Investigative Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40217

Country

United States

Facility Name

Novartis Investigative Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Novartis Investigative Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Novartis Investigative Site

City

Belzoni

State/Province

Mississippi

ZIP/Postal Code

39038

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39209

Country

United States

Facility Name

Novartis Investigative Site

City

Picayune

State/Province

Mississippi

ZIP/Postal Code

39466

Country

United States

Facility Name

Novartis Investigative Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59804

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Novartis Investigative Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Novartis Investigative Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Novartis Investigative Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Novartis Investigative Site

City

Roslyn

State/Province

New York

ZIP/Postal Code

11576

Country

United States

Facility Name

Novartis Investigative Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Novartis Investigative Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novartis Investigative Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Novartis Investigative Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28152

Country

United States

Facility Name

Novartis Investigative Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Novartis Investigative Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Novartis Investigative Site

City

Mogadore

State/Province

Ohio

ZIP/Postal Code

44260

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Novartis Investigative Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

Novartis Investigative Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Novartis Investigative Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Novartis Investigative Site

City

Murrells Inlet

State/Province

South Carolina

ZIP/Postal Code

29576

Country

United States

Facility Name

Novartis Investigative Site

City

Ninety Six

State/Province

South Carolina

ZIP/Postal Code

29666

Country

United States

Facility Name

Novartis Investigative Site

City

Varnville

State/Province

South Carolina

ZIP/Postal Code

29944

Country

United States

Facility Name

Novartis Investigative Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

Novartis Investigative Site

City

Fayetteville

State/Province

Tennessee

ZIP/Postal Code

33734

Country

United States

Facility Name

Novartis Investigative Site

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Facility Name

Novartis Investigative Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38125

Country

United States

Facility Name

Novartis Investigative Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76021

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

Facility Name

Novartis Investigative Site

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22911

Country

United States

Facility Name

Novartis Investigative Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Novartis Investigative Site

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Facility Name

Novartis Investigative Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novartis Investigative Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98004

Country

United States

Facility Name

Novartis Investigative Site

City

St-John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1E 2C2

Country

Canada

Facility Name

Novartis Investigative Site

City

St. John

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 5E8

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

Novartis Investigative Site

City

Sainte-Foy

State/Province

Quebec

ZIP/Postal Code

G1v 3M7

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 0H6

Country

Canada

Facility Name

Novartis Investigative Site

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Novartis Investigative Site

City

Loehne

ZIP/Postal Code

32584

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39110

Country

Germany

Facility Name

Novartis Investigative Site

City

Messkirch

ZIP/Postal Code

88605

Country

Germany

Facility Name

Novartis Investigative Site

City

Regensburg

ZIP/Postal Code

93053

Country

Germany

Facility Name

Novartis Investigative Site

City

Weener

ZIP/Postal Code

26826

Country

Germany

Facility Name

Novartis Investigative Site

City

Zwiesel

ZIP/Postal Code

94227

Country

Germany

Facility Name

Novartis Investigative Site

City

Bekescsaba

ZIP/Postal Code

H-5600

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Gyula

ZIP/Postal Code

5703

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szikszo

ZIP/Postal Code

3800

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

H-8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

51349

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

State/Province

ZIP/Postal Code

01117

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

09020

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

12. IPD Sharing Statement

Learn more about this trial

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

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

Acute Gouty Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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