NCT00783510

Juvenile Idiopathic Arthritis (JIA) Registry

A Long-term, Multi-center, Longitudinal Post-marketing, Observational Study to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA) - STRIVE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 849 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Juvenile Idiopathic Arthritis
• JIA

Interventions

Type	Name	Description
BIOLOGICAL	adalimumab	As prescribed by treating physician
DRUG	Methotrexate	As prescribed by treating physician

Timeline

• Start date: 2008-07-11
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2008-10-31
• Last updated: 2025-02-04

Locations

92 sites across 17 countries: United States, Australia, Austria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Portugal, Puerto Rico, Slovakia, Spain, Sweden