Study Stopped
See termination reason in detailed description.
Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
SINCERE
SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs
1 other identifier
observational
275
1 country
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Typical duration for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
July 19, 2013
CompletedFebruary 2, 2021
January 1, 2021
2.8 years
May 29, 2008
May 7, 2013
January 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Year 2 or early termination
Study Arms (2)
Celecoxib
Patients treated with celecoxib as per treating physician's judgement
nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)
Patients treated with nsNSAIDs as per treating physician's judgement
Interventions
Eligibility Criteria
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).
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Pfizer Investigational Site
Phoenix, Arizona, 85006, United States
Pfizer Investigational Site
Little Rock, Arkansas, 72202, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010, United States
Pfizer Investigational Site
Arlington Heights, Illinois, 60005, United States
Pfizer Investigational Site
Chicago, Illinois, 60637, United States
Pfizer Investigational Site
Glenview, Illinois, 60025, United States
Pfizer Investigational Site
New Lenox, Illinois, 60451, United States
Pfizer Investigational Site
Westchester, Illinois, 60154, United States
Pfizer Investigational Site
Omaha, Nebraska, 68114, United States
Pfizer Investigational Site
Hackensack, New Jersey, 07601, United States
Pfizer Investigational Site
Livingston, New Jersey, 07039, United States
Pfizer Investigational Site
Brooklyn, New York, 11211, United States
Pfizer Investigational Site
Brooklyn, New York, 11214, United States
Pfizer Investigational Site
Commack, New York, 11725, United States
Pfizer Investigational Site
Great Neck, New York, 11021, United States
Pfizer Investigational Site
New Hyde Park, New York, 11040, United States
Pfizer Investigational Site
New York, New York, 10016, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45229-3026, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Pfizer Investigational Site
Liberty Township, Ohio, 45044, United States
Pfizer Investigational Site
Mayfield Heights, Ohio, 44124, United States
Pfizer Investigational Site
Strongsville, Ohio, 44136, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19134-1095, United States
Pfizer Investigational Site
Charleston, South Carolina, 29425, United States
Pfizer Investigational Site
Nashville, Tennessee, 37232-9263, United States
Pfizer Investigational Site
Austin, Texas, 78723, United States
Related Publications (1)
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.
PMID: 25057265DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
April 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 2, 2021
Results First Posted
July 19, 2013
Record last verified: 2021-01