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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Arthritis, Juvenile Rheumatoid

Intervention / Treatment
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* Drug: Celecoxib
* Drug: nsNSAIDs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Celecoxib<br>Patients treated with celecoxib as per treating physician's judgement | Drug: Celecoxib<br>* Non-interventional: Treatment assignment as per treating physician's judgement<br>|
| nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)<br>Patients treated with nsNSAIDs as per treating physician's judgement | Drug: nsNSAIDs<br>* Non-interventional: Treatment assignment as per treating physician's judgement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celecoxib, COX-2, NSAIDs, observational study, noninterventional study, cohort study, registry, epidemiologic study, pediatrics, rheumatology, phase iv study