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Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 2)

Primary Purpose

Systemic Juvenile Idiopathic Arthritis With Active Flare

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

canakinumab

placebo

About this trial

This is an interventional treatment trial for Systemic Juvenile Idiopathic Arthritis With Active Flare focused on measuring Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile rheumatoid

Eligibility Criteria

2 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age.
-Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms
Active disease at the time of enrollment defined as follows:
- At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint)
- Documented spiking, intermittent fever (body temperature > 38oC) for at least 1 day during the screening period within 1 week before first study drug dose
- C-reactive protein > 30 mg/L (normal range < 10 mg/L)
No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of:
- Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice
- Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit
- Stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent

Exclusion criteria:

Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months
Risk factors for tuberculosis
Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection

Other protocol inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canakinumab

Placebo

Arm Description

In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.

Outcomes

Primary Outcome Measures

Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid

Ability to taper oral steroids: if dose reduced from start of Part I to end of Part Ic from > 0.8 mg/kg/day to ≤ 0.5 mg/kg/day, or from ≥ 0.5 mg/kg/day and ≤ 0.8 mg/kg/day by at least 0.3 mg/kg, or from any initial dose to ≤ 0.2 mg/kg/day, while maintaining a minimum adapted ACR 30 pediatric criterion. Patients on oral steroids at study entry who did not enter Part 1c are considered steroid tapering failures.

Part II: Survival Estimate of Time to Flare

Kaplan Meier estimate of the probability to experience a flare. Flare was defined as at least 1 of the following. Reappearance of fever (>38°C, lasting for at least 2 consecutive days) not due to infections Flare according to the JIA pediatric criteria for flare (all criteria must have been met): ≥ 30% worsening in at least 3 of the first 6 response variables ≥ 30% improvement in not more than 1 of the first 6 response variables Patients who discontinued the study while in Part II were counted as flared unless they discontinued because of inactive disease for at least 24 weeks in Part II.

Secondary Outcome Measures

Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic

Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c

Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I

Adapted ACR Pediatric 30/50/70/90/100 criteria are defined as meeting all of the following: improvement from baseline of ≥ 30%, ≥ 50%, ≥ 70%, ≥ 90%, or 100%, in at least 3 of the first 6 response variables Physician's global assessment of disease activity CHAQ-patient's overall well-being CHAQ-Functional ability # of joints with active arthritis # of joints with limitation of motion C-Reactive Protein. no intermittent fever in the preceding week no more than one of the first 6 response variables worsening by more than 30%

Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein

Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein

Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein

Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein

Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a

Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response

Kaplan Meier estimate of the time in days to the probability of worsening of the ACR response. ACR response is determined by the following items: Physician's global assessment of disease activity CHAQ-patient's overall wellbeing CHAQ-Functional ability Number of joints with active arthritis Number of joints with limitation of motion C-Reactive Protein. No intermittent fever in the preceding week

Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I

The childhood health assessment questionnaire, CHAQ was used to assess physical ability and functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Parents choose from four response categories, ranging from 0(without any difficulty) to 3(unable to do). A negative change indicates improvement.

Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)

CHAQ-DI assessed physical ability and functional status of patients and quality of life. 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and other "activities". Parents choose from 4 response categories, ranging from 0(without any difficulty) to 3(unable to do). Repeated measures Analysis of Covariance with treatment group, visit day, prednisone (or equivalent) dose and adapted ACR 70 response reached at the end of Part Id as covariates.

Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)

The CHQ-PF50© is an instrument used to measure Health Related Quality of Life in children 5-18 from the parent's perspective. The questionnaire measures the following concepts: Physical functioning, Role/social emotional, Role/social behavior, Role/social physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact - emotional, Parental impact - time, Family activities, and Family cohesion. Summaries are provided for Physical Health and Psychosocial Health. Scores range from 0-100. Increase in score represents improvement.

Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)

CHQ-PF50 measures Physical functioning, Role/social emotional, behavior and physical, Bodily pain, General behavior, Mental health, Self-esteem, General health perception, Change in health, Parental impact-emotional, Parental impact-time, Family activities and cohesion. Summaries are provided for Physical Health and Psychosocial Health. An increase in score indicates improvement. Repeated measures Analysis of Covariance change from start of Part II with treatment group, visit day, prednisone(or equivalent) dose and adapted ACR70 Pediatric response reached at the end of Part Id as covariates.

Full Information

NCT ID

NCT00889863

First Posted

April 21, 2009

Last Updated

September 13, 2012

Sponsor

Novartis Pharmaceuticals

Collaborators

Pediatric Rheumatology International Trials Organization

1. Study Identification

Unique Protocol Identification Number

NCT00889863

Brief Title

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

Acronym

β-SPECIFIC 2

Official Title

A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

Pediatric Rheumatology International Trials Organization

4. Oversight

5. Study Description

Brief Summary

This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

6. Conditions and Keywords

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

Systemic Juvenile Idiopathic Arthritis With Active Flare

Keywords

Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

canakinumab

Intervention Description

Canakinumab 4 mg/kg dose subcutaneous injection supplied as 6 mL glass vials each containing 150 mg canakinumab as a lyophilized cake.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo powder matching canakinumab supplied as 6 mL glass vials containing a lyophilized cake for subcutaneous injection every 4 weeks in Part II.

Primary Outcome Measure Information:

Title

Part I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid

Description

Time Frame

32 Weeks

Title

Part II: Survival Estimate of Time to Flare

Description

Time Frame

Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)

Secondary Outcome Measure Information:

Title

Part I: Percentage of Patients on Steroids at Study Start Who Reached a Steroid Dose ≤0.2 mg/kg at End of Part Ic

Time Frame

28 Weeks

Title

Part I: Percentage of Participants on Steroids at the Start of 1c Who Were Able to Taper Steroids by the End of Part 1c

Time Frame

Start of Part Ic (After Week 8) to End of Part Ic (Week 28)

Title

Part I: Percentage of Participants With Minimum American College of Rheumatology (ACR) 30/50/70/90/100 at the End of Part I

Description

Time Frame

Baseline, 32 Weeks

Title

Part I: Time to First Minimum American College of Rheumatology (ACR50) and Normal C-Reactive Protein

Description

Duration in days in the study to the first minimum adapted ACR Pediatric 50 criteria and a normal (<10mg/L) C-Reactive Protein

Time Frame

Baseline, Week 32

Title

Part I: Time to First Minimum American College of Rheumatology (ACR70) and Normal C-Reactive Protein

Description

Duration in days in the study to the first minimum adapted ACR Pediatric 70 criteria and a normal (<10mg/L) C-Reactive Protein

Time Frame

Baseline, Week 32

Title

Part I: Percentage of Participants With Body Temperature ≤ 38 Degrees Celsius at Day 3 in Part 1a

Time Frame

Day 3

Title

Part II: Survival Analysis of Time to a Worsening in American College of Rheumatology (ACR) Response

Description

Time Frame

Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)

Title

Part I: Change in Disability Over Time in the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI) From Baseline to End of Part I

Description

Time Frame

Baseline, End of Part I (Week 32)

Title

Part II: Change in Disability Over Time by the Child Health Assessment Questionnaire-Disability Index (CHAQ-DI)

Description

Time Frame

Start of Part II (Week 32), End of Part II ( total duration-88 weeks)

Title

Part I: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)

Description

Time Frame

Baseline, End of Part I ( Week 32)

Title

Part II: Change in Health Related Quality of Life Over Time by Child Health Questionnaire (CHQ-PF50)

Description

Time Frame

Start Part II (Week 32), End Part II (total duration - 88 Weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed diagnosis of systemic juvenile idiopathic arthritis as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with onset of disease < 16 years of age. -Arthritis in one or more joints with or preceded by fever of at least 2 weeks duration that is documented to be daily for at least 3 days with accompanying symptoms Active disease at the time of enrollment defined as follows: At least 2 joints with active arthritis (using American College of rheumatology) ACR definition of active joint) Documented spiking, intermittent fever (body temperature > 38oC) for at least 1 day during the screening period within 1 week before first study drug dose C-reactive protein > 30 mg/L (normal range < 10 mg/L) No concomitant use of second line agents such as disease-modifying and/ or immunosuppressive drugs will be allowed with the exception of: Stable dose of methotrexate for at least 8 weeks prior to the screening visit, and/or folic/folinic acid per standard medical practice Stable dose of no more than one non-steroidal anti-inflammatory drug for at least 2 weeks prior to the screening visit Stable dose of steroid treatment < or = to 1.0 mg/kg/day in 1-2 doses per day of oral prednisone or equivalent Exclusion criteria: Diagnosis of active macrophage-activation syndrome (MAS) within the last 6 months Risk factors for tuberculosis Patients with active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hepatitis B and Hepatitis C infection Other protocol 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

Arkansas Children's Hospital Research Inst

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

University of Chicago Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

University of Louisville

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

New England Medical Center - Department of Allergy

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

St Barnabas Ambulatory Care Center

City

Livingston

State/Province

New Jersey

ZIP/Postal Code

07039

Country

United States

Facility Name

Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Children's Hospital/Neurology

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Legacy Emanuel Hospital

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Legacy Emanual Research

City

Portland

State/Province

Oregon

ZIP/Postal Code

97232

Country

United States

Facility Name

Specially For Children

City

Austin

State/Province

Texas

ZIP/Postal Code

78723

Country

United States

Facility Name

Novartis Investigative Site

City

Buenos Aires

Country

Argentina

Facility Name

Novartis Investigative Site

City

Capital Federal

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

Country

Argentina

Facility Name

Novartis Investigative site

City

Bruxelles

Country

Belgium

Facility Name

Novartis Investigative site

City

Gent

Country

Belgium

Facility Name

Novartis Investigative Site

City

Laeken

Country

Belgium

Facility Name

Novartis Investigative site

City

Leuven

Country

Belgium

Facility Name

Novartis Investigative Site

City

Curitiba

Country

Brazil

Facility Name

Novartis Investigative site

City

Porto Alegre

Country

Brazil

Facility Name

Novartis Investigative site

City

Rio de Janiero

Country

Brazil

Facility Name

Novartis Investigative site

City

Sao Paulo

Country

Brazil

Facility Name

Novartis Investigative site

City

Vancouver

State/Province

British Columbia

Country

Canada

Facility Name

Novartis Investigative site

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

Novartis Investigative site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Novartis Investigative site

City

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Novartis Investigative Site

City

Le Kremlin Bicetre

Country

France

Facility Name

Novartis Investigative Site

City

Lyon

Country

France

Facility Name

Novartis Investigative Site

City

Paris

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg

Country

France

Facility Name

Novartis Investigative Site

City

Bad Bamstedt

Country

Germany

Facility Name

Novartis Investigative site

City

Berlin

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Geissen

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

Country

Germany

Facility Name

Novartis Investigative Site

City

Saint Augustin

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

Country

Hungary

Facility Name

Novartis Investigative Site

City

Haifa

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach-Tikva

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

Country

Israel

Facility Name

Novartis Investigative Site

City

Bologna

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

Country

Italy

Facility Name

Novartis Investigative site

City

Milano

Country

Italy

Facility Name

Novartis Investigative site

City

Napoli

Country

Italy

Facility Name

Novartis Investigative site

City

Padova

Country

Italy

Facility Name

Novartis Investigative site

City

Rome

Country

Italy

Facility Name

Novartis Investigative site

City

Scafati

Country

Italy

Facility Name

Novartis Investigative site

City

Torino

Country

Italy

Facility Name

Novartis Investigative site

City

Utrecht

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Oslo

Country

Norway

Facility Name

Novartis Investigative Site

City

Lima

Country

Peru

Facility Name

Novartis Investigative site

City

Warszawa

Country

Poland

Facility Name

Novartis Investigative site

City

Berea

State/Province

Durban

Country

South Africa

Facility Name

Novartis Investigative site

City

Mayville

State/Province

Durban

Country

South Africa

Facility Name

Novartis Investigative site

City

Johannesburg

Country

South Africa

Facility Name

Novartis Investigative site

City

Pretoria

Country

South Africa

Facility Name

Novartis Investigative site

City

Barcelona

Country

Spain

Facility Name

Novartis Investigative site

City

Madrid

Country

Spain

Facility Name

Novartis Investigative site

City

Valencia

Country

Spain

Facility Name

Novartis Investigative site

City

Stockholm

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bern

Country

Switzerland

Facility Name

Novartis Investigative site

City

Lausanne

Country

Switzerland

Facility Name

Novartis Investigative site

City

Zurich

Country

Switzerland

Facility Name

Novartis Investigative site

City

Ankara

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

30269054

Citation

Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29.

Results Reference

derived

PubMed Identifier

28115015

Citation

Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x.

Results Reference

derived

PubMed Identifier

26314396

Citation

Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group; Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407.

Results Reference

derived

PubMed Identifier

23252526

Citation

Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099.

Results Reference

derived

Links:

URL

http://www.novartisclinicaltrials.com

Description

Related Info

URL

http://www.juvenilearthritisresearch.com

Description

Related Info

Learn more about this trial

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)

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Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 2)

Systemic Juvenile Idiopathic Arthritis With Active Flare

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

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