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

Arthritis, Juvenile Rheumatoid Clinical Trial

— SINCERE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00688545
• Other study ID #: A3191344
• Status: Terminated
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 275
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid

Intervention

Drug:
• Celecoxib
Non-interventional: Treatment assignment as per treating physician's judgement
• nsNSAIDs
Non-interventional: Treatment assignment as per treating physician's judgement

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Arlington Heights	Illinois
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Brooklyn	New York
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Commack	New York
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Glenview	Illinois
United States	Pfizer Investigational Site	Great Neck	New York
United States	Pfizer Investigational Site	Hackensack	New Jersey
United States	Pfizer Investigational Site	Liberty Township	Ohio
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Livingston	New Jersey
United States	Pfizer Investigational Site	Mayfield Heights	Ohio
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Hyde Park	New York
United States	Pfizer Investigational Site	New Lenox	Illinois
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Phoenix	Arizona
United States	Pfizer Investigational Site	Strongsville	Ohio
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Westchester	Illinois

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   To obtain contact information for a study center near you, click here.