Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00048542

Purpose

This is a multicenter, Phase III randomized, placebo-controlled study in which polyarticular juvenile rheumatoid arthritis (JRA) subjects who are either methotrexate (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 244 weeks.

Condition	Intervention	Phase
Arthritis, Juvenile Rheumatoid	Drug: adalimumab Drug: adalimumab + methotrexate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Immunoglobulins Adalimumab Globulin, Immune

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

ACR30 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Disease flare [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Safety of adalimumab vs. placebo; evaluation of long-term safety profile of repeated subcutaneous injections in pediatric population [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Pharmacokinetic parameters [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical response indicators [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
ACR50 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Patient reported outcomes [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
ACR70 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Enrollment:	171
Study Start Date:	June 2002
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab: Experimental	Drug: adalimumab 20 mg eow (if < 30 kg) or 40 mg eow (if > 30 kg)
Adalimumab + methotrexate: Experimental	Drug: adalimumab + methotrexate adalimumab 20 mg eow (if < 30 kg) or 40 mg eow (if > 30 kg) plus methotrexate tablet

Eligibility

Ages Eligible for Study:	4 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048542

Show 35 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Laura Redden, MD, PhD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, Nemcova D, Mouy R, Sandborg C, Bohnsack J, Elewaut D, Foeldvari I, Gerloni V, Rovensky J, Minden K, Vehe RK, Weiner LW, Horneff G, Huppertz HI, Olson NY, Medich JR, Carcereri-De-Prati R, McIlraith MJ, Giannini EH, Martini A; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008 Aug 21;359(8):810-20.

Responsible Party:	Abbott ( Laura Redden )
Study ID Numbers:	DE038
Study First Received:	November 1, 2002
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00048542 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Polyarticular Juvenile Rheumatoid Arthritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Adalimumab
Antibodies, Monoclonal
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents

Connective Tissue Diseases
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009