Juvenile Idiopathic Arthritis (JIA) Registry (STRIVE)

• Incidence of Serious Adverse Events (SAEs) [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process.
• Incidence of Adverse Events (AEs) of Interest [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  Collected as events occur during the registry and as part of prior clinical studies. Events are collected retrospectively for patients who dosed prior to enrollment in the registry and as part of the Health Care Provider (HCP) process.

• Pediatric American College of Rheumatology (PedACR) - 30 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.
• PedACR50 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.
• PedACR70 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.
• PedACR90 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.
• Juvenile arthritis disease activity score [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
  Effectiveness data will be analyzed as observed and will be summarized for the All Treated Patient Population.

• Measure: PedACR30 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
• Measure: PedACR50 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
• Measure: PedACR70 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
• Measure: PedACR90 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

This is a global registry, to evaluate the long-term safety of Humira® in patients with moderate to severe polyarticular Juvenile Idiopathic Arthritis (JIA), that are treated as recommended in the Humira® product label. Patients treated with MTX will be considered a reference group. Patients will be followed in both the Humira® and Methotrexate (MTX) arms for 10 years.

The approved age range for HUMIRA in the U.S., EU and in Australia is 4 years of age and older. Patients who discontinue from the registry before 10 years will be offered to participate in the direct to Health Care Provider follow-up process.

Departments of rheumatology

• Biological: adalimumab
  As prescribed by treating physician
  Other Name: HUMIRA®
• Drug: Methotrexate
  As prescribed by treating physician
  Other Name: MTX

• HUMIRA® Treatment Arm
  For patients taking HUMIRA®
  Intervention: Biological: adalimumab
• Methotrexate Treatment Arm
  For patients taking Methotrexate
  Intervention: Drug: Methotrexate

Inclusion Criteria:

• For a patient enrolling into the HUMIRA® arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA) who has been prescribed HUMIRA® therapy according to the local approved HUMIRA® product labeling and meets one of the following criteria:
• Newly initiated (within 24 months of registry entry) on HUMIRA® therapy and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy, and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy; Or is entering after participation (within 24 months of registry entry or, if longer, continuously treated at the same site) in an Abbott sponsored study, regardless of age or the number of joints with symptoms of JIA, and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide available source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
• For a patient enrolling into the MTX arm; a pediatric patient diagnosed at any time with moderately to severely active polyarticular or polyarticular-course JIA (defined as arthritis affecting >= 5 joints at the time of diagnosis of polyarticular or polyarticular-course JIA) who is prescribed MTX therapy alone or in combination with other DMARDs according to the local product labeling (initiated treatment within 24 months of registry entry) and has received continuous therapy and the physician can available provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of therapy.
• Patients who were treated in the MTX arm of this registry and prematurely discontinued from the MTX arm due to being a non-responder, or became intolerant of MTX treatment or are in need of combination treatment with HUMIRA® therapy may be eligible to enroll into the HUMIRA® treatment arm if all ongoing AEs/SAEs have been resolved, and they meet inclusion criteria and can enroll within the registry enrollment period.
• Parent or guardian has voluntarily signed and dated an informed consent/patient authorization form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) if applicable according to local law, after the nature of the registry has been explained and the patient's parent or legal guardian has had the opportunity to ask questions. Pediatric patients will be included in all discussions as per applicable local regulations in order to obtain verbal or written assent.

Exclusion Criteria:

• Patients should not be enrolled into the HUMIRA® or Methotrexate (MTX) arm if they cannot be prescribed and treated in accordance with the approved local HUMIRA® and/or with the local MTX product label
• Patients should not be enrolled into the HUMIRA® or MTX arm if they require on-going treatment with Kineret® (anakinra), Rituxan® (rituximab), Enbrel® (etanercept), and Remicade® (infliximab), or any other approved biologic agents or investigational agents.
• Patients should not be enrolled into the MTX arm if they have had prior treatment with any investigational agent or anti-rheumatic biologic therapy such as, but not limited to, Orencia® (abatacept), Enbrel® (etanercept), Remicade® (infliximab), Rituxan® (rituximab), or Actemra® (tocilizumab)