Clinical trial NCT01544114: A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis (JIA)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Study with completed results acquired from Horizon in 2024.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
timeFrame: 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:
measure: Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])
timeFrame: pre-dose, and up to 3 hours post-dose
measure: PK of Esomeprazole: Oral Plasma Clearance (CL/F)
timeFrame: pre-dose, and up to 3 hours post-dose
measure: PK of Esomeprazole: Absorption Rate Constant (Ka)
timeFrame: pre-dose, and up to 3 hours post-dose
measure: PK of Esomeprazole: Oral Volume of Distribution (V/F)
timeFrame: pre-dose, and up to 3 hours post-dose
measure: PK of Naproxen: Trough Plasma Concentrations
timeFrame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: San Francisco
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Augusta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Toledo
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Fairfax
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.