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

Completed · Phase 4

Conditions studied: Juvenile Idiopathic Arthritis (JIA)

In brief

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

Key facts

Study ID

NCT01544114

Run by

Amgen

People needed

46

Starts

2012-04-01

Expected to finish

2015-02-01

Last updated by the study team

2024-12-17

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Research Site — Little Rock, Arkansas, United States
• Research Site — San Francisco, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Omaha, Nebraska, United States
• Research Site — Brooklyn, New York, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — New York, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Toledo, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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