Juvenile Idiopathic Arthritis (JIA)Phase 4NCT01544114
A Safety Study of VIMOVO in Adolescents With Juvenile Idiopathic Arthritis (JIA)
A Phase 4 study testing VIMOVO 250/20, VIMOVO 375/20 and VIMOVO 500/20 in people with Juvenile Idiopathic Arthritis (JIA), run by Amgen at 17 sites in United States.
Trial summary
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- VIMOVO 250/20, VIMOVO 375/20 and VIMOVO 500/20
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2012to Feb 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Research Site
Augusta, Georgia, 30912
Research Site
Aurora, Colorado, 80045
Research Site
Brooklyn, New York, 11203
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45229
Research Site
Cleveland, Ohio, 44195
Research Site
Fairfax, Virginia, 22030
Research Site
Little Rock, Arkansas, 72202
Research Site
Memphis, Tennessee, 38119
Research Site
New Hyde Park, New York, 11040
Research Site
New York, New York, 10021
Research Site
Omaha, Nebraska, 68114
Research Site
Philadelphia, Pennsylvania, 19134
Research Site
San Francisco, California, 94143
Research Site
Toledo, Ohio, 43623
Research Site
Washington D.C., District of Columbia, 20010
Research Site
West Palm Beach, Florida, 33407
About this study
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)
A 6-month study of the safety of VIMOVO in adolescents aged 12 to 16 years with JIA.
Read the detailed description
Study with completed results acquired from Horizon in 2024.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Being tested
- VIMOVO 250/20, VIMOVO 375/20, VIMOVO 500/20
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIMOVO 250/20Drug
Also called naproxen/esomeprazole
250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 375/20Drug
Also called naproxen/esomeprazole
375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
VIMOVO 500/20Drug
Also called naproxen/esomeprazole
500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
| Study group | Role | What they receive |
|---|---|---|
| VIMOVO | Experimental | 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. Receives: Drug: VIMOVO 250/20; Drug: VIMOVO 375/20; Drug: VIMOVO 500/20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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])
Measured: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
Measured: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Absorption Rate Constant (Ka)
Measured: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Volume of Distribution (V/F)
Measured: pre-dose, and up to 3 hours post-dose
PK of Naproxen: Trough Plasma Concentrations
Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.
Measured: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544114
- Sponsor's protocol ID
- D1120C00037
- Status last verified
- Nov 2024
- First submitted
- 21 Feb 2012
- Last updated
- 17 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29941047
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01544114
- Acronym / sponsor ID
- D1120C00037
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIMOVO | Experimental | Drug: VIMOVO 250/20, Drug: VIMOVO 375/20, Drug: VIMOVO 500/20Three 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. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIMOVO 250/20Also: naproxen/esomeprazole250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | Drug | VIMOVO |
| VIMOVO 375/20Also: naproxen/esomeprazole375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | Drug | VIMOVO |
| VIMOVO 500/20Also: naproxen/esomeprazole500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months | Drug | VIMOVO |
Primary outcome
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug
Time frame: 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.
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.
5 secondary outcomes
Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Plasma Clearance (CL/F)
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Absorption Rate Constant (Ka)
Time frame: pre-dose, and up to 3 hours post-dose
PK of Esomeprazole: Oral Volume of Distribution (V/F)
Time frame: pre-dose, and up to 3 hours post-dose
PK of Naproxen: Trough Plasma Concentrations
Time frame: Month 1 and Month 3: pre-dose, and up to 3 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29941047Lovell 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing VIMOVO 250/20, VIMOVO 375/20 and VIMOVO 500/20 in people with Juvenile Idiopathic Arthritis (JIA), run by Amgen at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544114, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.