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

January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Celecoxib
Patients treated with celecoxib as per treating physician's judgement
Drug: Celecoxib
Non-interventional: Treatment assignment as per treating physician's judgement
nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)
Patients treated with nsNSAIDs as per treating physician's judgement
Drug: nsNSAIDs
Non-interventional: Treatment assignment as per treating physician's judgement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to 2 years
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.
Year 2 or early termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 29, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (Estimate)

June 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 29, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3191344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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