Multicenter Study of Safety, Efficacy & Pharmacokinetics of Adalimumab (Humira) in Children w/Polyarticular JRA

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the

Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal

Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid

Arthritis

http://www.clinicaltrials.gov/ct/gui/show/NCT00048542?amp;order=4

This study is currently recruiting patients.

Sponsored by Abbott Laboratories

Purpose

This is a multicenter, Phase III randomized, placebo-controlled study in

which polyarticular JRA subjects who are either MTX treated or non-MTX

treated will initially receive Adalimumab by subcutaneous injection

every other week for a four-month open-label lead-in period. Subjects

who respond to the open-label therapy will then be rolled over into the

double-blind portion of the study and will be randomized to receive

either adalimumab or placebo for an additional 32 weeks or until flare

of disease, whichever is earlier. Subjects who experience disease flare

during the double-blind portion of the study or subjects who complete 48

weeks of the study will be given the option to receive open-label

treatment with adalimumab for an additional 44 weeks.

Study Type: Interventional

Study Design: Treatment

Eligibility

Ages Eligible for Study: 4 Years - 17 Years, Genders Eligible for

Study: Both

Criteria

* Subjects must have a diagnosis of Polyarticular JRA age 4 to 17

by the ACR criteria. Disease onset may have been systemic,

polyarticular, or pauciarticular. If the disease was systemic onset,

then the subjects must be free of any systemic JRA manifestations for at

least 3 months before the time of qualification.

* At the time of study screening, the subject must have continuing

active disease defined as ?5 swollen joints and ?3 joints with

limitation of motion (LOM). These joints are not mutually exclusive.

* Subjects may be either naïve to MTX, inadequate responders to

MTX, or intolerant to MTX. Intolerance to MTX will be defined by the

subject’s physician. The MTX must be maintained at a dose of at least 10

mg/m2 BSA/week for a minimum of 3 months, prior to screening.

* Duration of disease is not limited, but must have been long

enough for a subject to have been given an adequate trial of NSAIDs.

* Have not received other DMARDs including penicillamine,

hydroxychloroquine, sulfasalazine, oral or injectable gold, cyclosporin;

or IV immunoglobulin (IV Ig); or cytotoxic agents, for at least 4 weeks

prior to receiving 1st dose of study drug. Subjects currently on one or

more of these DMARDs must demonstrate active disease (defined above)

prior to a minimum 4 weeks (28 days) washout of all DMARDs.

* Subjects who are refractory to MTX after 3 months of treatment

must demonstrate active disease (defined above) prior to enrollment in

the open-label part of the trial.

* Have not received an intra-articular glucocorticoid injection

within 4 weeks (28 days) prior to enrollment into the study.

* Have good venous access and stable hematocrit ? 24%.

* All sexually active male and female study participants must be

practicing adequate contraception. Post-pubertal females must have a

negative serum pregnancy test no greater than 10 days prior to the first

dose of study drug. 10. Parent or guardian has voluntarily signed and

dated an informed consent form, approved by an Institutional Review

Board (IRB)/Independent Ethics Committee (IEC), after the nature of the

study has been explained and the subject’s parent or legal guardian has

had the opportunity to ask questions.

Location and Contact Information

Monika Miranda (973)-394-5514 monika.miranda@...

Alabama

Childrens Hospital of Alabama, Birmingham, Alabama, 35233,

United States; Recruiting

Atkinson, MD 205-934-7054

Atkinson, MD, Principal Investigator

California

Stanford University Medical Center, Stanford, California,

94305, United States; Recruiting

Christy Sandborg,, M.D. 650-723-8295 sandborg@...

Christy Sandborg, MD, Principal Investigator

Children's Hospital Los Angeles, Los Angeles, California,

90027, United States; Recruiting

s Reiff, MD 323-699-2119 reiff@...

s Reiff, MD, Principal Investigator

Florida

Arthritis Associates of South Florida, Delray Beach, Florida,

33484, United States; Recruiting

561-638-0956

Goodman, MD, Principal Investigator

All Children's Hospital, St. sburg, Florida, 33701,

United States; Recruiting

Olcay , MD 727-892-8428 joneso@...

Olcay , MD, Principal Investigator

Illinois

LaRabida Children's Hospital and Research Center, Chicago,

Illinois, 60649, United States; Recruiting

Wagner-Weiner, MD 773-363-6700 Ext. ext392 LWW@...

Wanger-Weiner, MD, Principal Investigator

Kansas

University of Kansas Medical Center, Kansas City, Kansas,

66160, United States; Recruiting

Nacy Olson, MD 913-649-3335 nolson@...

Olson, MD, Principal Investigator

Michigan

University of Michigan Health System, Ann Arbor, Michigan,

48109, United States; Recruiting

Barbara , MD 734-764-2224 barbad@...

Barbara , MD, Principal Investigator

Minnesota

University of Minnesota, Minneapolis, Minnesota, 55455, United

States; Recruiting

Vehe, M.D. 612-626-4873 vehex001@...

Vehe, MD, Principal Investigator

Nebraska

Children's Hospital, Omaha, Nebraska, 68178, United States;

Recruiting

Lawrence Jung, M.D. 402-955-4070 lkljung@...

Lawrence Jung, MD, Principal Investigator

New Jersey

St. Barnabas Medical Center, Livingston, New Jersey, 09039,

United States; Recruiting

Chalom, MD 973-322-7438 echalom@...

Chalom, MD, Principal Investigator

North Carolina

University of North Carolina at Chapel Hill, Chapel Hill, North

Carolina, 27514, United States; Recruiting

Leonard Stein,, M.D. 919-966-2331 leonard_stein@...

Leonard Stein,, MD, Principal Investigator

Duke University Medical Center, Durham, North Carolina, 27710,

United States; Terminated

Ohio

Children's Hospital, Columbus, Ohio, 43205, United States;

Recruiting

Gloria Higgins,, M.D. 614-722-5525 higginsg@...

Gloria Higgins, MD, Principal Investigator

Utah

University of Utah Health Sciences Center, Salt Lake City, Utah,

84132, United States; Recruiting

801-581-5319 john.bohnsack@...

Bohnsack, MD, Principal Investigator

Virginia

Children's Hospital of the King's Daughters, Norfolk, Virginia,

23507, United States; Recruiting

Christos ,, M.D. 757-668-8572 cgabriel@...

Christos , MD, Principal Investigator

Belgium

UZ Gasthuisberg Leuven, Leunen, 3000, Belgium; Recruiting

Carrine Wouters, MD +32-16-33-22-11 carine.wouters@...

Carine Wouters, MD, Principal Investigator

UZ Gent, GENT, 9000, Belgium; Recruiting

Veys, MD + 32 9 240 25 20

Veys, MD, Principal Investigator

France

Groupe Hospitalier Necker-Enfants Malades, Paris, 75015,

France; Recruiting

Anne-Marie Prieur, MD +33 1-44 49 48 28

Anne-Marie Prieur, MD, Principal Investigator

France, CEDEX

Hospital Nord De Marseille, Marseille, CEDEX, 20 13915,

France; Recruiting

Isabelle K Paut, MD +33 4-91 96 87 50

Isabelle K Paut, MD, Principal Investigator

Germany

Allgemeines Krankenhaus Eilbeck, Hamburg, 22081, Germany; Recruiting

Ivan Foeldvari, MD +49-40-2092-3694

foeldvari@...kinderrheuma (DOT) de

Ivan Foeldcari, MD, Principal Investigator

Rheumakinderklinik Garmisch-Partenkirchen,

Garmisch-Partenkirchen, 82467, Germany; Recruiting

Hartmut Michels, MD +49-88-21-70-11-18 Hartmut.Michels@...

Hartmut Michels, MD, Principal Investigator

Zentralkrankenhaus, Prof. Hess Kinderklinik, Bremen, 27205,

Germany; Recruiting

Hans-Iko Huppertz, MD +49-421-497-54-11 huppertz.bremen@...

Hans-Iko Huppertz, MD, Principal Investigator

Italy

Clinica Pediatrica II " De Marchi " , Milano, 20122, Italy; Recruiting

Fabrizia Corona, MD +39-02-57-99-24-59 fcorona@...

Fabrizia Corona, MD, Principal Investigator

Irccs Istituto G. Gaslini, Genova, 16147, Italy; Recruiting

Alberto i, MD +39 010-56 36 386

Alberto i, MD, Principal Investigator

Instituto Gaetano Pini, Milano, 20122, Italy; Recruiting

Flavio Fantini, MD +39 02-583157712

Flavio Fantini, MD, Principal Investigator

Slovakia

Narodny ustav reumatickych chorob, Piestany, 921 01, Slovakia;

Recruiting

Jozef Rovensky, MD +421 33-7723508

Jozef Rovensky, MD, Principal Investigator

Klinika deti a dorastu FN s poliklinikou, Kosice, 04001,

Slovakia; Recruiting

Vesely, MD +421 903-61 15 11

Vesely, MD, Principal Investigator

Spain

Hospital Universitario " La Paz " Hospital Infantil, Madrid,

28034, Spain; Recruiting

Consuerga, MD +34 91-727 7164

Consuegra, Principal Investigator

Hospital Ramon Y Cajal, Madrid, 28034, Spain; Recruiting

Gamir Gamir, MD +34 91-336 8751

Gamir Gamir, MD, Principal Investigator

More Information

Study ID Numbers DE038

Record last reviewed June 2003

NLM Identifier NCT00048542

ClinicalTrials.gov processed this record on 2004-07-16