Conditions: Juvenile Idiopathic Arthritis (JIA)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 46
Healthy volunteers: no

Brief summary:
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms:
arm 1: Three VIMOVO strengths will be used in this study: 250 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 250/20), 375 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 375/20), and 500 mg naproxen/20 mg esomeprazole magnesium (VIMOVO 500/20). The VIMOVO strength allocated to each participant will be determined by the participant's weight at baseline and based on investigator's discretion.

The target dose of the naproxen component will be within the range of 10-20 mg/kg/day divided twice daily (BID) with a maximum daily dose of 1000 mg.

Interventions: intervention 1: VIMOVO 250/20 intervention 2: VIMOVO 375/20 intervention 3: VIMOVO 500/20
Intervention descriptions: intervention 1: 250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months intervention 2: 375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months intervention 3: 500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Protocol document: