Arthritis, Juvenile RheumatoidSINCERENCT00688545

Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis

An observational study of Arthritis, Juvenile Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 27 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This multi-center observational Registry will collect long-term safety data on patients treated with celecoxib or non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) as used in clinical practice for the treatment of Juvenile Idiopathic Arthritis (JIA). 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 nsNSAIDs
How many people: 275 participants
Where: 27 sitesUnited States
Study dates: Apr 2009to Jan 2012
Phase: Observational
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

Study population: Juvenile Idiopathic Arthritis (JIA) subtypes that correspond to the former Juvenile Rheumatoid Arthritis (JRA) classification system who are treated by a participating pediatric rheumatologist and treated with either celecoxib or an nsNSAID; celecoxib or nsNSAID must be new treatment or recent initiation (within last 6 months).

Who may be able to join

Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).

Who cannot join

Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
Patients who need to use multiple NSAIDs at the same time.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

Pfizer Investigational Site
Arlington Heights, Illinois, 60005
Pfizer Investigational Site
Austin, Texas, 78723
Pfizer Investigational Site
Brooklyn, New York, 11211
Pfizer Investigational Site
Brooklyn, New York, 11214
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Cincinnati, Ohio, 45229-3026
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Commack, New York, 11725
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Glenview, Illinois, 60025
Pfizer Investigational Site
Great Neck, New York, 11021
Pfizer Investigational Site
Hackensack, New Jersey, 07601
Pfizer Investigational Site
Liberty Township, Ohio, 45044
Pfizer Investigational Site
Little Rock, Arkansas, 72202
Pfizer Investigational Site
Livingston, New Jersey, 07039
Pfizer Investigational Site
Mayfield Heights, Ohio, 44124
Pfizer Investigational Site
Nashville, Tennessee, 37232-9263
Pfizer Investigational Site
New Hyde Park, New York, 11040
Pfizer Investigational Site
New Lenox, Illinois, 60451
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19134-1095
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Strongsville, Ohio, 44136
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
Westchester, Illinois, 60154

Other trials in United States

About this study

Official title: SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs

Read the detailed description

None Study has been terminated early (LSLV = 09Jan2012) due to release of the postmarketing commitment by the US FDA. The study was stopped for futility/change in treatment paradigm that minimizes chronic NSAID use and not for safety concerns.

Conditions: Arthritis, Juvenile Rheumatoid
Being tested: Celecoxib, nsNSAIDs
Keywords: Celecoxib, COX-2, NSAIDs, observational study, noninterventional study, cohort study, registry, epidemiologic study, pediatrics, rheumatology, phase iv study
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
Non-interventional: Treatment assignment as per treating physician's judgement
nsNSAIDsDrug
Non-interventional: Treatment assignment as per treating physician's judgement

Study groups in NCT00688545
Study group	Role	What they receive
Celecoxib		Patients treated with celecoxib as per treating physician's judgement Receives: Drug: Celecoxib
nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)		Patients treated with nsNSAIDs as per treating physician's judgement Receives: Drug: nsNSAIDs

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.
Measured: Baseline up to 2 years
JIA Concomitant Medications
JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.
Measured: Year 2 or early termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Jan 2012

First posted3 Jun 2008 (estimated)
Study startApr 2009
Primary completionJan 2012
Study completionJan 2012

Why it stopped: See termination reason in detailed description.

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 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00688545
Sponsor's protocol ID: A3191344
Acronym: SINCERE
Status last verified: Jan 2021
First submitted: 29 May 2008
Last updated: 2 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sobel RE, Lovell DJ, Brunner HI, Weiss JE, Morris PW, Gottlieb BS, Chalom EC, Jung LK, Onel KB, Petiniot L, Goldsmith DP, Nanda K, Shishov M, Abramsky S, Young JP, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry. Pediatr Rheumatol Online J. 2014 Jul 16;12:29. doi: 10.1186/1546-0096-12-29. eCollection 2014.
PubMed 25057265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
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All Arthritis, Juvenile Rheumatoid trials

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: SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs
ClinicalTrials.gov ID: NCT00688545
Acronym / sponsor ID: SINCERE / A3191344
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Celecoxib, COX-2, NSAIDs, observational study, noninterventional study, cohort study, registry, epidemiologic study
Study type: Observational
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 275 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 3 Jun 2008 (estimated)
Results: Posted 19 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Celecoxib	–	Drug: CelecoxibPatients treated with celecoxib as per treating physician's judgement
nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)	–	Drug: nsNSAIDsPatients treated with nsNSAIDs as per treating physician's judgement

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Juvenile Idiopathic Arthritis (JIA) subtypes that correspond to the former Juvenile Rheumatoid Arthritis (JRA) classification system who are treated by a participating pediatric rheumatologist and treated with either celecoxib or an nsNSAID; celecoxib or nsNSAID must be new treatment or recent initiation (within last 6 months).

Key inclusion criteria (2 listed)

Age at least 2 years but less than 18 years; JIA of any of the following subtypes: oligoarthritis, polyarthritis, or stable systemic disease;
new treatment (started not more than 6 months prior) with one NSAID (celecoxib or nsNSAID).

Key exclusion criteria (3 listed)

Patients with the following JIA subtypes: active systemic disease, psoriatic Arthritis, enthesitis-related Arthritis, or undifferentiated arthritis;
Patients with Reiter's syndrome; patients unlikely to complete 2 years of follow up;
Patients who need to use multiple NSAIDs at the same time.

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
CelecoxibNon-interventional: Treatment assignment as per treating physician's judgement	Drug	Celecoxib
nsNSAIDsNon-interventional: Treatment assignment as per treating physician's judgement	Drug	nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)

Primary outcome

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 2 years
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. AEs attributed to the NSAID (celecoxib or nsNSAID) utilized at time of event, regardless of the initial NSAID treatment at Registry entry.
JIA Concomitant Medications
Time frame: Year 2 or early termination
JIA medications by class: GI protective agents (eg, proton-pump inhibitors, antacids, surcalfate), other GI, DMARDs, biologics, antihypertensives, NSAIDs (Celecoxib, Diclofenac, Ibuprofen, Meloxicam, Naproxen, other NSAIDs), corticosteroids (oral, IV, intra-articular, other forms), analgesics Acetaminophen, Opioids, other). Participants could receive more than 1 medication.

Results and safety

Results posted to the registry on 19 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib	55	50
nsNSAIDs	219	204

Primary outcome: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to 2 years. Number. Unit: Participants

Measure	Celecoxib n = 68	nsNSAIDs n = 225
AEs	36	117
SAEs	2	9

Population analysed: Safety Analysis Set: participants who were prescribed at least one dose of any NSAID. Participants who switched treatment were counted for the NSAID utilized at the time of the event, regardless of the initial NSAID treatment at enrollment.

Primary outcome: JIA Concomitant Medications

Time frame: Year 2 or early termination. Number. Unit: Participants

Measure	Celecoxib n = 39	nsNSAIDs n = 148
GI protective agents	20	54
Other GI	5	8
DMARDs	24	102
Biologics	13	60
Antihypertensives	1	4
NSAIDs (Celecoxib)	7	2
NSAIDs (Diclofenac)	0	0
NSAIDs (Ibuprofen)	1	9

Population analysed: Safety Analysis Set subset of participants who received JIA concomitant medications

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	2 of 68 (2.9%)	35 of 68 (51.5%)	Not reported
nsNSAIDs	9 of 225 (4%)	114 of 225 (50.7%)	Not reported

Limitations and caveats (from the sponsor): Study terminated prematurely: Sponsor released by FDA from post-marketing commitment. As a result, only a small number of participants/analyses could be performed, data must be interpreted with caution. Endpoints arbitrarily assigned as primary.

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.
Derived from this study: PubMed 25057265Sobel RE, Lovell DJ, Brunner HI, Weiss JE, Morris PW, Gottlieb BS, Chalom EC, Jung LK, Onel KB, Petiniot L, Goldsmith DP, Nanda K, Shishov M, Abramsky S, Young JP, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry. Pediatr Rheumatol Online J. 2014 Jul 16;12:29. doi: 10.1186/1546-0096-12-29. eCollection 2014.
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

27 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Juvenile Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 27 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 2 inclusion and 3 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: stopped early, 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 27 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2013). 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 With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 2 years). The study lists 2 primary outcomes in all. 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 NCT00688545, 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 2 Feb 2021.