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

NCT ID: NCT01544114

Last Updated: 2024-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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Study with completed results acquired from Horizon in 2024.

Conditions

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Juvenile Idiopathic Arthritis (JIA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

VIMOVO 250/20

Intervention Type DRUG

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

VIMOVO 375/20

Intervention Type DRUG

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

VIMOVO 500/20

Intervention Type DRUG

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

Interventions

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VIMOVO 250/20

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

Intervention Type DRUG

VIMOVO 375/20

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

Intervention Type DRUG

VIMOVO 500/20

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

Intervention Type DRUG

Other Intervention Names

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naproxen/esomeprazole naproxen/esomeprazole naproxen/esomeprazole

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Little Rock, Arkansas, United States

Site Status

Research Site

San Francisco, California, United States

Site Status

Research Site

Aurora, Colorado, United States

Site Status

Research Site

Washington D.C., District of Columbia, United States

Site Status

Research Site

West Palm Beach, Florida, United States

Site Status

Research Site

Augusta, Georgia, United States

Site Status

Research Site

Chicago, Illinois, United States

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Research Site

Omaha, Nebraska, United States

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Research Site

Brooklyn, New York, United States

Site Status

Research Site

New Hyde Park, New York, United States

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Research Site

New York, New York, United States

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Research Site

Cincinnati, Ohio, United States

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Research Site

Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Research Site

Memphis, Tennessee, United States

Site Status

Research Site

Fairfax, Virginia, United States

Site Status

Countries

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United States

References

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Lovell DJ, Dare JA, Francis-Sedlak M, Ball J, LaMoreaux BD, Von Scheven E, Reinhardt A, Jerath R, Alpan O, Gupta R, Goldsmith D, Zeft A, Naddaf H, Gottlieb B, Jung L, Holt RJ. A 6-month, multicenter, open-label study of fixed dose naproxen/esomeprazole in adolescent patients with juvenile idiopathic arthritis. Pediatr Rheumatol Online J. 2018 Jun 26;16(1):41. doi: 10.1186/s12969-018-0260-y.

Reference Type DERIVED
PMID: 29941047 (View on PubMed)

Related Links

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http://www.vimovo.com/

Related Info

Other Identifiers

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D1120C00037

Identifier Type: -

Identifier Source: org_study_id