Phase 4
N=46
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
Juvenile Idiopathic Arthritis (JIA)
Bottom Line
View on ClinicalTrials.gov: NCT01544114 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Oct 2017
Primary outcome: Primary: Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug — 4; 16; 17; 37 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VIMOVO 250/20 (Drug); VIMOVO 375/20 (Drug); VIMOVO 500/20 (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug |
4; 16; 17; 37; 1; 9 | — |
| SECONDARY Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t]) |
2.2; 1.3; 1.2; 1.3 | — |
| SECONDARY PK of Esomeprazole: Oral Plasma Clearance (CL/F) |
27; 44; 47; 43 | — |
| SECONDARY PK of Esomeprazole: Absorption Rate Constant (Ka) |
2.8; 2.6; 4.1; 3.3 | — |
| SECONDARY PK of Esomeprazole: Oral Volume of Distribution (V/F) |
28; 61; 57; 55 | — |
| SECONDARY PK of Naproxen: Trough Plasma Concentrations |
63.09; 19.29; 40.71; 63.16; 33.91; 40.69 | — |
Summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
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.
Data sourced from ClinicalTrials.gov (NCT01544114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.