A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)

Amgen

Status and phase: Completed; Phase 4

Conditions: Juvenile Idiopathic Arthritis (JIA)

Treatments: Drug: VIMOVO 375/20; Drug: VIMOVO 500/20; Drug: VIMOVO 250/20

Study type: Interventional

Funder types: Industry

Identifiers

NCT01544114

D1120C00037

Details and patient eligibility

About

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

Full description

Study with completed results acquired from Horizon in 2024.

Enrollment: 46 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parent or legal guardian is able to provide written informed consent and patient is able to provide written assent if appropriate.
• Male and female adolescents aged 12 to 16 years at the time of enrollment.
• Diagnosed with JIA, including all the International League of Associations for Rheumatology JIA subtypes: oligoarthritis, polyarthritis (both rheumatoid factor [RF]+ and RF-), psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis, and systemic arthritis.
• Based upon investigator judgment, it is determined appropriate for the patient to undergo 6 months of continuous treatment with VIMOVO.
• Body weight > 31 kg (68.2 lbs) and within the 5th to 95th percentile of body mass index for age.

Exclusion criteria

• In systemic JIA patients, presence of systemic features (ie, fever, rheumatoid rash, serositis, lymphadenopathy, macrophage activation syndrome) within 6 months prior to start of study drug.
• Currently taking (ie, within 4 weeks prior to start of drug) naproxen > 20 mg/kg/day or > 1000 mg total daily dose.
• Hemoglobin ≤ 8.5 g/dL.
• Individuals who have cardiovascular or cerebrovascular disease, based on history or risk factors.
• Any significant hepatic, renal, pulmonary, ophthalmologic, neurologic, or any other medical conditions indicated by medical/surgical history, physical, or laboratory examination that might put the patient at greater risk during the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

VIMOVO

Experimental group

Description:

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.

Treatment:

Drug: VIMOVO 250/20

Drug: VIMOVO 500/20

Drug: VIMOVO 375/20