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Completed

NCT Number: NCT01544114

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

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

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Key information

Conditions

Juvenile Idiopathic Arthritis (JIA) Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Little Rock, Arkansas, United States

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About this study

Study with completed results acquired from Horizon in 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VIMOVO 250/20

Drug

250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Other names: naproxen/esomeprazole

VIMOVO 375/20

Drug

375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Other names: naproxen/esomeprazole

VIMOVO 500/20

Drug

500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months

Other names: naproxen/esomeprazole

Primary outcomes

  1. Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug

    Time frame: 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.

    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.

Secondary outcomes

  1. Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])

    Time frame: pre-dose, and up to 3 hours post-dose

  2. PK of Esomeprazole: Oral Plasma Clearance (CL/F)

    Time frame: pre-dose, and up to 3 hours post-dose

  3. PK of Esomeprazole: Absorption Rate Constant (Ka)

    Time frame: pre-dose, and up to 3 hours post-dose

  4. PK of Esomeprazole: Oral Volume of Distribution (V/F)

    Time frame: pre-dose, and up to 3 hours post-dose

  5. PK of Naproxen: Trough Plasma Concentrations

    Time frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose

    Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2012
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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