A Study of Tocilizumab in Patients With Active Systemic jia

[Guest guest]

A Study of Tocilizumab in Patients With Active Systemic Juvenile

Idiopathic Arthritis

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, December 2008

Sponsored by: Hoffmann-La Roche

Information provided by: Hoffmann-La Roche

ClinicalTrials.gov Identifier: NCT00642460

Purpose

This study will evaluate the efficacy and safety of tocilizumab in

patients with active systemic juvenile idiopathic arthritis (sJIA)

who have an inadequate clinical response to NSAIDs and

corticosteroids. In Part 1 of the study patients will be randomized

2:1 to receive iv infusions of tocilizumab (8mg/kg iv for patients

>=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks.

Stable NSAIDs and methotrexate will be continued throughout. After 12

weeks of double-blind treatment, all patients will have the option to

enter Part 2 of the study to receive open-label treatment with

tocilizumab for a further 92 weeks. The anticipated time on study

treatment is 2 years, and the target sample size is 100-500

individuals.

Condition Intervention Phase

Juvenile Idiopathic Arthritis

Drug: tocilizumab

Drug: Placebo

Drug: NSAIDs + methotrexate

Phase III

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:Interventional

Study Design:Treatment, Randomized, Double Blind (Subject, Caregiver,

Investigator, Outcomes Assessor), Parallel Assignment,

Safety/Efficacy Study

Official Title:A Randomized, Placebo-Controlled Study to Evaluate the

Effect of Tocilizumab on Disease Response in Patients With Active

Systemic Juvenile Idiopathic Arthritis, With an Open-Label Extension

to Examine the Long Term Use of Tocilizumab

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients with >=30% improvement in JIA core set and

absence of fever [ Time Frame: Week 12 ] [ Designated as safety

issue: No ]

Secondary Outcome Measures:

% patients with 30/50/70/90% improvement in JIA core set; reduction

in steroid use; change in individual components of JIA core set;

change in hsCRP, anemia, platelet count, total WBC, incidence of

rash;improvement in CHAQ, and VAS [ Time Frame: Week 12 ] [

Designated as safety issue: No ]

Time from baseline to achievement of JIA ACR 30/50/70/90 [ Time

Frame: Throughout study ] [ Designated as safety issue: No ]

AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as

safety issue: No ]

Estimated Enrollment:108

Study Start Date:May 2008

Estimated Study Completion Date:February 2012

Arms Assigned Interventions

1: Experimental Drug: tocilizumab

8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks

for 12 weeks

Drug: NSAIDs + methotrexate

As prescribed

2: Placebo Comparator Drug: Placebo

iv every 2 weeks for 12 weeks

Drug: NSAIDs + methotrexate

As prescribed

Eligibility

Ages Eligible for Study:2 Years to 17 Years

Genders Eligible for Study:Both

Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:

patients aged 2-17 years of age;

systemic JIA with >= 6 months persistent activity;

presence of active disease (>=5 active joints, or >=2 active joints +

fever + steroids);

inadequate clinical response to NSAIDs and corticosteroids due to

toxicity or lack of efficacy.

Exclusion Criteria:

wheelchair or bed-ridden;

any other autoimmune, rheumatic disease or overlap syndrome other

than sJIA;

intravenous long-acting corticosteroids or intra-articular

corticosteroids within 4 weeks of baseline, or throughout study;

DMARDs (other than methotrexate);

previous treatment with tocilizumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier:

NCT00642460

Contacts

Contact: Please reference Study ID Number: WA18221 973-235-5000

Contact: or 800-526-6367 (FOR US ONLY)

Hide Study Locations

Locations

United States, Arkansas

Recruiting

LITTLE ROCK, Arkansas, United States, 45229-3039

United States, California

Not yet recruiting

LOS ANGELES, California, United States, 90027

United States, Connecticut

Recruiting

HARTFORD, Connecticut, United States, 06106

United States, Georgia

Not yet recruiting

AUGUSTA, Georgia, United States, 30912

United States, Illinois

Recruiting

CHICAGO, Illinois, United States, 60649

United States, Kentucky

Recruiting

LOUISVILLE, Kentucky, United States, 40202-3906

United States, New Jersey

Recruiting

HACKENSACK, New Jersey, United States, 07601

Recruiting

LIVINGSTON, New Jersey, United States, 07039

United States, North Carolina

Recruiting

DURHAM, North Carolina, United States, 27710

United States, Ohio

Recruiting

CINCINNATI, Ohio, United States, 45229

Recruiting

CLEVELAND, Ohio, United States, 44195

United States, Oklahoma

Recruiting

OKLAHOMA CITY, Oklahoma, United States, 73104

United States, Pennsylvania

Not yet recruiting

PITTSBURGH, Pennsylvania, United States, 15213

United States, Texas

Not yet recruiting

HOUSTON, Texas, United States, 77030

Argentina

Not yet recruiting

BUENOS AIRES, Argentina, 1425

Not yet recruiting

BUENOS AIRES, Argentina, 1245

Not yet recruiting

LA PLATA, Argentina, 1900

Not yet recruiting

BUENOS AIRES, Argentina, 1181

Not yet recruiting

CÓRDOBA, Argentina, 5000

Not yet recruiting

BUENOS AIRES, Argentina, 1270

Australia

Recruiting

PARKVILLE, Australia, 3052

Recruiting

SUBIACO, Australia, 6008

Recruiting

WESTMEAD, Australia, 2145

Belgium

Recruiting

LEUVEN, Belgium, 3000

Recruiting

GENT, Belgium, 9000

Brazil

Not yet recruiting

SAO PAULO, Brazil, 05403-900

Not yet recruiting

PORTO ALEGRE, Brazil, 90035-003

Not yet recruiting

RIO DE JANEIRO, Brazil, 20551-030

Canada, British Columbia

Recruiting

VANCOUVER, British Columbia, Canada, V6H 3V4

Canada, Nova Scotia

Recruiting

HALIFAX, Nova Scotia, Canada, B3J 3G9

Canada, Ontario

Recruiting

OTTAWA, Ontario, Canada, K1H 8L1

Recruiting

TORONTO, Ontario, Canada, M5G 1X8

Czech Republic

Recruiting

PRAHA, Czech Republic, 121-09

Denmark

Not yet recruiting

COPENHAGEN, Denmark, 2100

Not yet recruiting

ÅRHUS, Denmark, 8200

France

Not yet recruiting

PARIS, France, 75015

Not yet recruiting

LE KREMLIN BICÊTRE, France, 94270

Not yet recruiting

PARIS, France, 75014

Not yet recruiting

BRON, France, 69677

Germany

Not yet recruiting

HAMBURG, Germany, 22149

Recruiting

SANKT AUGUSTIN, Germany, 53757

Recruiting

BERLIN, Germany, 13353

Recruiting

BREMEN, Germany, 28205

Greece

Recruiting

HERAKLION, Greece, 71110

Not yet recruiting

ATHENS, Greece, 11527

Recruiting

IOANNINA, Greece, 45332

Italy

Recruiting

MILANO, Italy, 20122

Recruiting

PADOVA, Italy, 35128

Not yet recruiting

ROMA, Italy, 00165

Recruiting

GENOVA, Italy, 16147

Mexico

Recruiting

MEXICO CITY, Mexico, 06720

Recruiting

MEXICO CITY, Mexico, 06700

Netherlands

Not yet recruiting

LEIDEN, Netherlands, 2333 AA

Not yet recruiting

Utrecht, Netherlands, 3584 AE

Norway

Recruiting

OSLO, Norway, 0027

Poland

Recruiting

LUBLIN, Poland, 20-093

Slovakia

Recruiting

PIESTANY, Slovakia, 921 01

Spain

Recruiting

ESPLUGAS DE LLOBREGAT, Spain, 08950

Recruiting

MADRID, Spain, 28046

Recruiting

BARCELONA, Spain, 08035

Recruiting

VALENCIA, Spain, 46009

Sweden

Recruiting

GOETEBORG, Sweden, 41685

United Kingdom

Recruiting

LONDON, United Kingdom, WCIN 1EN

Not yet recruiting

LIVERPOOL, United Kingdom, L12 2AP

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:Hoffmann-La Roche ( Clinical Trials, Study

Director )

Study ID Numbers:WA18221, 2007-000872-18

First Received:March 19, 2008

Last Updated:December 2, 2008

ClinicalTrials.gov Identifier:NCT00642460 [history]

Health Authority:United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid

Autoimmune Diseases

Arthritis, Juvenile Rheumatoid

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Methotrexate

Rheumatic Diseases