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Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

Primary Purpose

Systemic Juvenile Idiopathic Arthritis

Status

Terminated

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 focused on measuring Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile Rheumatoid, Systemic juvenile idiopathic arthritis with active flare

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 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/quotidian for at least 3 days and accompanied by one or more of the following:
- evanescent nonfixed erythematous rash,
- generalized lymph node enlargement,
- hepatomegaly and/ or splenomegaly,
- serositis
Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age
Male and female patients aged ≥ 2 to < 20 years of age
Active disease at the time of enrollment defined as follows:
- At least 2 joints with active arthritis
- Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose
- C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
Naïve to canakinumab
Other protocol defined inclusion criteria may apply

Exclusion Criteria:

Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study:

Pregnant or nursing (lactating) female patients
Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception
History of hypersensitivity to study drug or to biologics.
Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months
With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection
Other protocol defined exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canakinumab

Placebo

Arm Description

Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.

Patients received a single dose matching placebo of canakinumab on day 1.

Outcomes

Primary Outcome Measures

Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria

Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)

Secondary Outcome Measures

Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria

Adapted ACR Pediatric 50 criteria determined responders (improved from baseline of at least 50% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30%) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP (mg/L)

Percentage of Patients Achieving the Adapted ACR Pediatric 70

Adapted ACR Pediatric 70 criteria determined responders (improved from baseline of at least 70% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)

Percentage of Patients Achieving the Adapted ACR Pediatric 90

Adapted ACR Pediatric 90 criteria determined responders (improved from baseline of at least 90% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation CRP(mg/L)

Percentage of Patients Achieving the Adapted ACR Pediatric 100

Adapted ACR Pediatric 100 criteria determined responders (ie improved from baseline of at least 100% in at least 3 response variables 1-6 and no intermittent fever in preceding week [variable 7], with no more than one variable 1-6 worsening > 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2. Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4. Number of joints with active arthritis 5. Number of joints with limited of motion 6. Laboratory measure of inflammation

Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)

CHAQ assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty' (0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.

Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ

CHAQ, assessed physical ability and functional status of patients as well as quality of life. The disability dimension consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). The parent's or patient's pain assessment was on VAS that was part of CHAQ. The VAS scale ranges from no pain (0 mm) to very severe pain (100 mm). Negative change indicates improvement.

Percentage of Patients Who Had Body Temperature ≤ 38°C

Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.

Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)

CHQ-PF50 measures HRQoL in children 5-18 years old from parent's perspective. Questionnaire completed by parent without input from patient. Total score ranges from 0-100. Increases in scores represent improved well-being in subjects as assessed by their parents. Mixed linear model on change from baseline in CHQ-PF50 score with treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Covariance analysis used a repeated measures approach, so all timepoints over time were taken into account.

Change in Disability Score Over Time by Use of the CHAQ

The disability dimension of CHAQ consisted of 20 multiple choice items about difficulty in doing eight common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Four response categories range from 'without any difficulty'(0) to 'unable to do' (3). Mixed linear model on change from baseline in CHAQ score included treatment group, stratification factors, day of assessment and interaction between group and day as covariates. Negative change indicates improvement.

Full Information

NCT ID

NCT00886769

First Posted

April 22, 2009

Last Updated

February 28, 2017

Sponsor

Novartis Pharmaceuticals

Collaborators

International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Southwest Pediatric Nephrology Study Group

1. Study Identification

Unique Protocol Identification Number

NCT00886769

Brief Title

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

Acronym

β-SPECIFIC 1

Official Title

A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

recommendation by Data Monitoring Committee

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

Collaborators

International Maternal Pediatric Adolescent AIDS Clinical Trials Group, Southwest Pediatric Nephrology Study Group

4. Oversight

5. Study Description

Brief Summary

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

6. Conditions and Keywords

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

Systemic Juvenile Idiopathic Arthritis

Keywords

Flare, arthritis, IL-1beta antagonist, systemic juvenile idiopathic arthritis, Juvenile Rheumatoid, Systemic juvenile idiopathic arthritis with active flare

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Canakinumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patients received a single dose matching placebo of canakinumab on day 1.

Intervention Type

Drug

Intervention Name(s)

Canakinumab

Other Intervention Name(s)

ACZ885

Intervention Description

Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

Primary Outcome Measure Information:

Title

Percentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria

Description

Time Frame

Baseline, Day 15, Day 29

Secondary Outcome Measure Information:

Title

Percentage of Patients Achieving the Adapted ACR Pediatric 50 Criteria

Description

Time Frame

Baseline, Day 15, Day 29

Title

Percentage of Patients Achieving the Adapted ACR Pediatric 70

Description

Time Frame

Baseline, Day 15, Day 29

Title

Percentage of Patients Achieving the Adapted ACR Pediatric 90

Description

Time Frame

Baseline, Day 15, Day 29

Title

Percentage of Patients Achieving the Adapted ACR Pediatric 100

Description

Time Frame

baseline, Day 15, Day 29

Title

Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS)as Part of the Childhood Health Assessment Questionnaire(CHAQ)

Description

Time Frame

Baseline, Day 15

Title

Change in Patient's Pain Intensity as Assessed on a 100-mm Visual Analog Scale (VAS) as Part of CHAQ

Description

Time Frame

Baseline, Day 29

Title

Percentage of Patients Who Had Body Temperature ≤ 38°C

Description

Body temperature was derived from vital signs evaluation. No conversion of body temperature was performed, no matter how it was measured.

Time Frame

Day 3

Title

Change in Health-related Quality of Life (HRQoL)Over Time by Use of the Child Health Questionnaire - Parent Form (CHQ-PF50)

Description

Time Frame

Over 4 week study period (Baseline, Day 15, Day 29)

Title

Change in Disability Score Over Time by Use of the CHAQ

Description

Time Frame

At 4 week study period

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 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/quotidian for at least 3 days and accompanied by one or more of the following: evanescent nonfixed erythematous rash, generalized lymph node enlargement, hepatomegaly and/ or splenomegaly, serositis Parent's or legal guardian's written informed consent and child's assent, if appropriate, or patient's informed consent for ≥ 18 years of age Male and female patients aged ≥ 2 to < 20 years of age Active disease at the time of enrollment defined as follows: At least 2 joints with active arthritis Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day during the screening period within 1 week before first canakinumab/placebo dose C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L) Naïve to canakinumab Other protocol defined inclusion criteria may apply Exclusion Criteria: Patients who fulfilled one or more of the following criteria were not eligible for inclusion in this study: Pregnant or nursing (lactating) female patients Female patients having reached sexual maturity unless their career, lifestyle, or sexual orientation precluded intercourse with a male partner and/or they were using an acceptable method of contraception History of hypersensitivity to study drug or to biologics. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) within the last 6 months With active or recurrent bacterial, fungal or viral infection, including patients with evidence of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C infection Other protocol defined 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

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

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 Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

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

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Tufts New England Medical Center-Dept. of Allergy

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

Cinncinati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Nationwide Children's Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

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 Janeiro

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

Calgary

Country

Canada

Facility Name

Novartis Investigative site

City

Arhus N

Country

Denmark

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

Strassbourg

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

Dresden

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

Country

Germany

Facility Name

Novartis Investigative site

City

Garmisch-Partenkirch

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

Hannover

Country

Germany

Facility Name

Novartis Investigative site

City

Krefeld

Country

Germany

Facility Name

Novartis Investigative site

City

Mainz

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

Tubingen

Country

Germany

Facility Name

Novartis Investigative site

City

Thessaloniki

Country

Greece

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

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

Facility Name

Novartis Investigative site

City

Birmingham

Country

United Kingdom

Facility Name

Novartis Investigative site

City

Liverpool

Country

United Kingdom

Facility Name

Novartis Investigative site

City

London

Country

United Kingdom

Facility Name

Novartis Investigative site

City

Manchester

Country

United Kingdom

Facility Name

Novartis Investigative site

City

New Castle Upon Tyne

Country

United Kingdom

Facility Name

Novartis Investigative site

City

Norwich

Country

United Kingdom

Facility Name

Novartis Investigative site

City

Oxford

Country

United Kingdom

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

Click here for more information about this study

URL

http://www.juvenilearthritisresearch.com

Description

Related Info

Learn more about this trial

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

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Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) (β-SPECIFIC 1)

Systemic Juvenile Idiopathic Arthritis

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