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Trial record 1 of 1 for:    NCT00688545
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Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis (SINCERE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00688545
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 3, 2008
Results First Posted : July 19, 2013
Last Update Posted : February 2, 2021
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Brief 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).

Condition or disease Intervention/treatment
Arthritis, Juvenile Rheumatoid Drug: Celecoxib Drug: nsNSAIDs

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.

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Study Type : Observational
Actual Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00688545

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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72202
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20010
United States, Illinois
Pfizer Investigational Site
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
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Pfizer Investigational Site
Hackensack, New Jersey, United States, 07601
Pfizer Investigational Site
Livingston, New Jersey, United States, 07039
United States, New York
Pfizer Investigational Site
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
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
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
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-9263
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78723
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Identifier: NCT00688545    
Other Study ID Numbers: A3191344
First Posted: June 3, 2008    Key Record Dates
Results First Posted: July 19, 2013
Last Update Posted: February 2, 2021
Last Verified: January 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
observational study
noninterventional study
cohort study
epidemiologic study
phase iv study
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action