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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 Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as 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. 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 Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects frequently get the finest healthcare available for their 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 condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Arthritis, Juvenile Rheumatoid
Status: Recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 4 Years/17 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Narodny ustav reumatickych chorob *Recruiting*
Piestany, , 921 01
Slovakia
Recruiting Jozef Rovensky +421 33-7723508
Children's Hospital *Recruiting*
Columbus, Ohio, 43205
United States
Recruiting Gloria Higgins 614-722-5525
UZ Gent *Recruiting*
GENT, , 9000
Belgium
Recruiting Eric Veys + 32 9 240 25 20
Clinica Pediatrica II "De Marchi" *Recruiting*
Milano, 20122, ,
Italy
Recruiting Fabrizia Corona +39-02-57-99-24-59
LaRabida Children's Hospital and Research Center *Recruiting*
Chicago, Illinois, 60649
United States
Recruiting Linda Wagner-Weiner 773-363-6700
Childrens Hospital of Alabama *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Thomas Atkinson 205-934-7054
Allgemeines Krankenhaus Eilbeck *Recruiting*
Hamburg, 22081, ,
Germany
Recruiting Ivan Foeldvari +49-40-2092-3694
Irccs Istituto G. Gaslini *Recruiting*
Genova, , 16147
Italy
Recruiting Alberto Martini +39 010-56 36 386
University of Minnesota *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Richard Vehe 612-626-4873
Hospital Nord De Marseille *Recruiting*
Marseille, CEDEX, 20 13915
France
Recruiting Isabelle Paut +33 4-91 96 87 50
University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160
United States
Recruiting Nacy Olson 913-649-3335
Children's Hospital *Recruiting*
Omaha, Nebraska, 68178
United States
Recruiting Lawrence Jung 402-955-4070
Children's Hospital of the King's Daughters *Recruiting*
Norfolk, Virginia, 23507
United States
Recruiting Christos Gabriel 757-668-8572
St. Barnabas Medical Center *Recruiting*
Livingston, New Jersey, 09039
United States
Recruiting Elizabeth Chalom 973-322-7438
Groupe Hospitalier Necker-Enfants Malades *Recruiting*
Paris, , 75015
France
Recruiting Anne-Marie Prieur +33 1-44 49 48 28
Arthritis Associates of South Florida *Recruiting*
Delray Beach, Florida, 33484
United States
Recruiting 561-638-0956
University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27514
United States
Recruiting Leonard Stein 919-966-2331
University of Michigan Health System *Recruiting*
Ann Arbor, Michigan, 48109
United States
Recruiting Barbara Adams 734-764-2224
Zentralkrankenhaus, Prof. Hess Kinderklinik *Recruiting*
Bremen, 27205, ,
Germany
Recruiting Hans-Iko Huppertz +49-421-497-54-11
All Children's Hospital *Recruiting*
St. Petersburg, Florida, 33701
United States
Recruiting Olcay Jones 727-892-8428
Stanford University Medical Center *Recruiting*
Stanford, California, 94305
United States
Recruiting Christy Sandborg 650-723-8295
Duke University Medical Center *Terminated*
Durham, North Carolina, 27710
United States
Terminated
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027
United States
Recruiting Andreas Reiff 323-699-2119
Hospital Universitario "La Paz" Hospital Infantil *Recruiting*
Madrid, , 28034
Spain
Recruiting Julia Consuerga +34 91-727 7164
Rheumakinderklinik Garmisch-Partenkirchen *Recruiting*
Garmisch-Partenkirchen, 82467, ,
Germany
Recruiting Hartmut Michels +49-88-21-70-11-18
UZ Gasthuisberg Leuven *Recruiting*
Leunen, 3000, ,
Belgium
Recruiting Carrine Wouters +32-16-33-22-11
Klinika deti a dorastu FN s poliklinikou *Recruiting*
Kosice, , 04001
Slovakia
Recruiting Richard Vesely +421 903-61 15 11
Hospital Ramon Y Cajal *Recruiting*
Madrid, , 28034
Spain
Recruiting Maria Gamir +34 91-336 8751
University of Utah Health Sciences Center *Recruiting*
Salt Lake City, Utah, 84132
United States
Recruiting 801-581-5319
Instituto Gaetano Pini *Recruiting*
Milano, , 20122
Italy
Recruiting Flavio Fantini +39 02-583157712
Additional Information:
Study ID Numbers: DE038;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048542
Other Arthritis, Juvenile Rheumatoid Studies:
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2. ENBREL(R) (Etanercept) Safety Study in Children with Juvenile Rheumatoid Arthritis
3. The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
4. 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
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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
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