Arthritis, Juvenile RheumatoidPhase 4NCT00807846
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
A Phase 4 study testing Celecoxib and Naproxen in people with Arthritis, Juvenile Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in 10 countries.
Trial summary
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Arthritis, Juvenile Rheumatoid
- What is being tested?
- Celecoxib and Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 39 sitesin 10 countries
- Study dates
- Sep 2009to Dec 2012
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
- Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
- ≥2 years of age and <18 years of age prior to the Baseline visit
- Body weight ≥10 kg at the Baseline visit
- Candidate for chronic NSAID therapy in the Investigator's judgment
Who cannot join
- Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
- Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
- Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
- Subjects with active Systemic JIA should not be enrolled
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
United States18 sites
Akron Children's Hospital
Akron, Ohio, 44308
Arthritis Associates of South Florida
Delray Beach, Florida, 33484
Delray Research Associates
Delray Beach, Florida, 33484
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Administrative Site-Hawaii Pacific Health Research Institute
Honolulu, Hawaii, 96813
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Kosair Charities Pediatric Clinical Research Unit - University of Louisville
Louisville, Kentucky, 40202
Kosair Children's Hospital
Louisville, Kentucky, 40202
University of Louisville
Louisville, Kentucky, 40202
University Pediatric Rheumatology of Kentucky
Louisville, Kentucky, 40202
Miami Children's Hospital
Miami, Florida, 33155-3009
Children's Hospital and Medical Center
Omaha, Nebraska, 68114
University of Nebraska Medical Center Pediatric Research Office
Omaha, Nebraska, 68198-5456
Children's Hospital-San Diego
San Diego, California, 92123
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704
Children's National Medical Center / Division of Rheumatology
Washington D.C., District of Columbia, 20010
Ukraine5 sites
Department of Cardioreumatology
Kharkiv, 61153
Institute of Pediatrics, Obstetrics and Gynecology
Kiev, 04050
Kyiv City Children Clinical Hospital #1
Kyiv, 04209
Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
Simferopol, 95034
Zaporizhzhya Regional Clinical Pediatric Hospital
Zaporizhzhya, 69063
Russia4 sites
State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
Moscow, 105077
First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
Moscow, 119992
Smolensk Regional Clinical Hospital
Smolensk, 214000
SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
Smolensk, 214019
Chile2 sites
Hospital Regional de Concepcion Guillermo Grant Benavente
Concepción, Biobio, 4070038
Hospital Roberto del Rio
Santiago, RM, 8380418
Peru2 sites
Clinica San Borja/Centro de Investigacion de Reumatologia
San Borja, Lima region, L41
Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia
San Isidro, Lima region, L27
Philippines2 sites
Philippine General Hospital
Manila, 1000
University of Santo Tomas Hospital
Manila, 1008
Serbia2 sites
Institute of Rheumatology
Belgrade, 11000
Children's Clinic of Internal Medicine
Niš, 18000
Switzerland2 sites
CHUV - Unit of Immuno-Allergology and Rhumatology
Ch-1011 Lausanne
Universitaets-Kinderspital
Ch-8032 Zuerich
About this study
Official title: A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
- Conditions
- Arthritis, Juvenile Rheumatoid
- Being tested
- Celecoxib, Naproxen
- Keywords
- Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
NaproxenDrug
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Experimental | Not described Receives: Drug: Celecoxib |
| Naproxen | Experimental | Not described Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Value at 6 weeks minus value at baseline.
Measured: 6 Weeks/Final Visit
Secondary outcomes (9)
Change From Baseline to Week 2 in SBP.
Value at 2 weeks minus value at baseline.
Measured: 2 weeks
Change From Baseline in SBP at Week 4.
Value at 4 weeks minus value at baseline.
Measured: 4 weeks
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Value at 2 weeks minus value at baseline.
Measured: 2 weeks
Change From Baseline in DBP at Week 4.
Value at 4 weeks minus value at baseline.
Measured: 4 weeks
Change From Baseline in DBP at Week 6/Final Visit
Value at 6 weeks/Final Visit minus value at baseline.
Measured: 6 weeks
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Measured: 6 weeks
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
Measured: Week 6/Final Visit
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Measured: 6 weeks
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
Measured: Week 6/Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
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.
- Other trials for Arthritis, Juvenile RheumatoidStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807846
- Sponsor's protocol ID
- A3191342
- Status last verified
- Jan 2021
- First submitted
- 10 Dec 2008
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, 6-week, Randomized Double Blind, Multicenter, Active-controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis.
- ClinicalTrials.gov ID
- NCT00807846
- Acronym / sponsor ID
- A3191342
- Conditions
- Arthritis, Juvenile Rheumatoid
- Keywords
- Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Posted 11 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: Celecoxib |
| Naproxen | Experimental | Drug: Naproxen |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
- Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
- ≥2 years of age and <18 years of age prior to the Baseline visit
- Body weight ≥10 kg at the Baseline visit
- Candidate for chronic NSAID therapy in the Investigator's judgment
Key exclusion criteria (4 listed)
- Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
- Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
- Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
- Subjects with active Systemic JIA should not be enrolled
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 |
|---|---|---|
| CelecoxibCelecoxib 50 mg or 100 mg PO BID for 6 weeks | Drug | Celecoxib |
| NaproxenNaproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks | Drug | Naproxen |
Primary outcome
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Time frame: 6 Weeks/Final Visit
Value at 6 weeks minus value at baseline.
9 secondary outcomes
Change From Baseline to Week 2 in SBP.
Time frame: 2 weeks
Change From Baseline in SBP at Week 4.
Time frame: 4 weeks
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Time frame: 2 weeks
Change From Baseline in DBP at Week 4.
Time frame: 4 weeks
Change From Baseline in DBP at Week 6/Final Visit
Time frame: 6 weeks
Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
Time frame: 6 weeks
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
Time frame: Week 6/Final Visit
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
Time frame: 6 weeks
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
Time frame: Week 6/Final Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib and Naproxen in people with Arthritis, Juvenile Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 39 sites in 10 countries.
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 4 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Ukraine, Russia, Chile, Peru and 5 more countries. 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 11 Nov 2015). 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?
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit (time frame: 6 Weeks/Final Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2021.