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

Juvenile Idiopathic Arthritis (JIA) Clinical Trial

Official title:

A 6-month, Multicenter, Open-label, Safety Study of VIMOVO (250 mg/20 mg, 375 mg/20 mg, and 500 mg/20 mg Naproxen/Esomeprazole) in Adolescents Aged 12 to 16 Years, Inclusive, With Juvenile Idiopathic Arthritis (JIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544114
• Other study ID #: D1120C00037
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2012
• Last updated: September 7, 2017
• Start date: April 2012
• Est. completion date: February 2015

Study information

• Verified date: September 2017
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis (JIA)

Intervention

Drug:
• VIMOVO 250/20
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
• VIMOVO 375/20
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
• VIMOVO 500/20
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Locations

Country	Name	City	State
United States	Research Site	Augusta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Brooklyn	New York
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Fairfax	Virginia
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Memphis	Tennessee
United States	Research Site	New Hyde Park	New York
United States	Research Site	New York	New York
United States	Research Site	Omaha	Nebraska
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	San Francisco	California
United States	Research Site	Toledo	Ohio
United States	Research Site	Washington, D.C.	District of Columbia
United States	Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug	An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.	SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.
Secondary	Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])		pre-dose, and up to 3 hours post-dose
Secondary	PK of Esomeprazole: Oral Plasma Clearance (CL/F)		pre-dose, and up to 3 hours post-dose
Secondary	PK of Esomeprazole: Absorption Rate Constant (Ka)		pre-dose, and up to 3 hours post-dose
Secondary	PK of Esomeprazole: Oral Volume of Distribution (V/F)		pre-dose, and up to 3 hours post-dose
Secondary	PK of Naproxen: Trough Plasma Concentrations	Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.	Month 1 and Month 3: pre-dose, and up to 3 hours post-dose

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