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

November 25, 2024 updated by: Amgen

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study with completed results acquired from Horizon in 2024.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Research Site
    • California
      • San Francisco, California, United States, 94143
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Research Site
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Research Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Research Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Research Site
      • New Hyde Park, New York, United States, 11040
        • Research Site
      • New York, New York, United States, 10021
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Cleveland, Ohio, United States, 44195
        • Research Site
      • Toledo, Ohio, United States, 43623
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19134
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Virginia
      • Fairfax, Virginia, United States, 22030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VIMOVO

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
Time Frame: pre-dose, and up to 3 hours post-dose
pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Absorption Rate Constant (Ka)
Time Frame: pre-dose, and up to 3 hours post-dose
pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Volume of Distribution (V/F)
Time Frame: pre-dose, and up to 3 hours post-dose
pre-dose, and up to 3 hours post-dose
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.
Month 1 and Month 3: pre-dose, and up to 3 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimated)

March 5, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1120C00037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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