A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
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)
1 other identifier
interventional
46
1 country
17
Brief Summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2012
Typical duration for phase_4
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
October 4, 2017
CompletedDecember 17, 2024
November 1, 2024
2.8 years
February 21, 2012
August 4, 2017
November 25, 2024
Conditions
Outcome Measures
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
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 Outcomes (5)
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
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Absorption Rate Constant (Ka)
pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Volume of Distribution (V/F)
pre-dose, and up to 3 hours post-dose
PK of Naproxen: Trough Plasma Concentrations
Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
Study Arms (1)
VIMOVO
EXPERIMENTALThree 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.
Interventions
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (17)
Research Site
Little Rock, Arkansas, 72202, United States
Research Site
San Francisco, California, 94143, United States
Research Site
Aurora, Colorado, 80045, United States
Research Site
Washington D.C., District of Columbia, 20010, United States
Research Site
West Palm Beach, Florida, 33407, United States
Research Site
Augusta, Georgia, 30912, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Omaha, Nebraska, 68114, United States
Research Site
Brooklyn, New York, 11203, United States
Research Site
New Hyde Park, New York, 11040, United States
Research Site
New York, New York, 10021, United States
Research Site
Cincinnati, Ohio, 45229, United States
Research Site
Cleveland, Ohio, 44195, United States
Research Site
Toledo, Ohio, 43623, United States
Research Site
Philadelphia, Pennsylvania, 19134, United States
Research Site
Memphis, Tennessee, 38119, United States
Research Site
Fairfax, Virginia, 22030, United States
Related Publications (1)
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.
PMID: 29941047DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Julie Ball, Executive Director of Clinical Development & Operations
- Organization
- Horizon Pharma, Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
March 5, 2012
Study Start
April 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
December 17, 2024
Results First Posted
October 4, 2017
Record last verified: 2024-11