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 from the enrollment date into one of the treatment arms.
This registry will assess the incidence and rate of Humira (monotherapy or combination therapy with MTX) or MTX observational and treatment-emergent SAEs, Adverse Events of Special Interest (AESI) and Pregnancy in patients diagnosed with moderately to severely active polyarticular or polyarticular-course JIA through Year 5. From Year 6 through Year 10 SAEs, a subset of AESI that includes congestive heart failure (CHF), malignancies, AEs at least possibly related to and/or leading to discontinuation of registry treatment and pregnancies will be collected. For JIA patients 2 to\< 4 years of age in countries with available local approval for this group of patients at the time of consent to the registry, emergent AESI, SAEs and pregnancy (at the age when a patient can become pregnant) will be collected for the full 10 years. The approved age range for HUMIRA in the U.S., European Union (EU) and in Australia is 4 years of age and older, and recent approval in EU for JIA patients 2 to \< 4 years of age. Patients who discontinue from the registry before 10 years will be offered to participate in the direct to Health Care Provider follow-up process, as allowed by local regulations.
Study Type
OBSERVATIONAL
Enrollment
849
As prescribed by treating physician
As prescribed by treating physician
Incidence of Serious Adverse Events (SAEs)
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.
Time frame: Up to 10 years
Incidence of Adverse Events (AEs) of Interest
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.
Time frame: Up to 10 years
Pediatric American College of Rheumatology (PedACR) 50
Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Time frame: Up to 10 years
Pediatric American College of Rheumatology (PedACR) 70
Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Time frame: Up to 10 years
Pediatric American College of Rheumatology (PedACR) - 30
Effectiveness data will be analyzed as observed and will be summarized for All the Treated Patient Population.
Time frame: Up to 10 years
Child Health Questionnaire (CHQ-PF50)
The results will be summarized at each visit and will be used in exploratory analyses.
Time frame: Assessed in months 1,3, 6 and every 6 months through Year 5
Pediatric American College of Rheumatology (PedACR) 90
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AZ Arthritis and Rheumotology Research, PLLC /ID# 21023
Phoenix, Arizona, United States
Catalina Pointe Clinical Research /ID# 40227
Tucson, Arizona, United States
Arkansas Children's Hospital /ID# 23505
Little Rock, Arkansas, United States
Children's Hospital Los Angeles /ID# 24386
Los Angeles, California, United States
Children's National Medical Center /ID# 23506
Washington D.C., District of Columbia, United States
Duplicate_Arthritis Associates South FL /ID# 17001
Delray Beach, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 20966
Chicago, Illinois, United States
The University of Chicago Medical Center /ID# 21981
Chicago, Illinois, United States
Methodist Medical Group Rheum /ID# 46343
Peoria, Illinois, United States
Indiana University /ID# 11421
Indianapolis, Indiana, United States
...and 82 more locations
Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population.
Time frame: Up to 10 years
Juvenile arthritis disease activity score (JADAS)
Effectiveness data will be analyzed as observed and will be summarized for All Treated Patient Population. Is the total scores of four activity scales (Physician's Global Assessment of patient's disease, Parents' Global Assessment of patient's overall well-being, Number of active joints and Normalized erythrocyte sedimentation rate (ESR) if collected and available.
Time frame: Assessed in months 1,3, 6 and every 6 months through Year 5
Physical function of the Disability Index of Childhood Health Assessment Questionnaire (DIHAQ)
Effectiveness of therapy through clinical assessment.
Time frame: Assessed in months 1,3, 6 and every 6 months through Year 5