Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
Condition: Arthritis, Juvenile Idiopathic
MeSH terms: Arthritis; Arthritis, Juvenile
Intervention: Double-Blind Adalimumab/Placebo + MTX; Double-Blind Adalimumab/Placebo; OLE BSA Adalimumab +/- MTX; OLE FD Adalimumab +/- MTX
Intervention description: Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) concomitantly with MTX treatment for 32 weeks during the Double-Blind phase. Total body dose of adalimumab was not to exceed 40 mg.; Subcutaneous injection of 24 mg adalimumab or placebo per square meter of body surface area (BSA) every other week (eow) without MTX treatment for 32 weeks during the Double-Blind Phase. Total body dose of adalimumab was not to exceed 40 mg.; Comparison of subcutaneous injection of 24 mg adalimumab per square meter of body surface area (BSA) every other week (eow) either with or without concomitant MTX treatment for a minimum of 44 weeks (up to a maximum of 136 weeks) during the Open-Label Extension BSA Phase.; Comparison of adalimumab administered subcutaneously every other week (eow) either with or without concomitant MTX treatment for up to 224 weeks during the Open-Label Extension Fixed Dose (FD) Phase.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 171.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Polyarticular Juvenile Idiopathic Arthritis

Summary:

      This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate
      adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis
      (JIA) who are either methotrexate (MTX) treated or non-MTX treated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a diagnosis of polyarticular juvenile idiopathic arthritis (JIA)
             age 4 to 17 by the American College of Rheumatology (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 JIA 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 body surface area/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 nonsteroidal anti-inflammatory drugs (NSAIDs).

          -  Have not received other disease-modifying anti-rheumatic drugs (DMARDs) including
             penicillamine, hydroxychloroquine, sulfasalazine, oral or injectable gold,
             cyclosporin; or intravenous 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.

          -  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.

        Exclusion Criteria:

          -  Pregnant or nursing female.

          -  Functional class IV by ACR criteria.

          -  Laboratory parameters outside limits established in the protocol.

          -  Medical history, medical condition, or previous treatment not allowed by the protocol.