Active Juvenile Idiopathic Arthritis (JIA) Compassionate Use

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT00775437
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 4 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab solution for injection for subcutaneous use.

Study Details

The main objective of this study is to evaluate the safety of adalimumab in patients 2 to \< 4 years of age or ≥ 4 years of age weighing \< 15 kg, with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) or polyarticular course JIA.

Key Dates

Start date
Mar 31, 2009
Status verified
Dec 2015
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab
    Adalimumab 24 mg/m\^2 body surface area (BSA) up to a total dose of 20 mg administered every other week (eow) by parent or designee as a single dose via subcutaneous injection at approximately the same time of day, for a minimum of 24 weeks. Participants could continue in the study until age 4 and 15 kg (US and Puerto Rico) or for up to 1 additional year after reaching age 4 and 15 kg (EU). Visits beyond Week 24 occurred every 12 weeks for those participants who continued in the study.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: TEAEs were collected from first dose of study drug until 70 days after the last dose of study drug and before start of commercial adalimumab or other biologics (32.5 months). ]

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