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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00688545 |
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 | Intervention | Phase |
---|---|---|
Arthritis, Juvenile Rheumatoid |
Drug: Celecoxib Drug: nsNSAIDs |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, 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 |
Estimated Enrollment: | 400 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Celecoxib
Patients treated with celecoxib as per treating physician's judgement
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Drug: Celecoxib
Non-interventional: Treatment assignment as per treating physician's judgement
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nsNSAIDs (nonselective nonsteroidal anti-inflammatory drugs)
Patients treated with nsNSAIDs as per treating physician's judgement
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Drug: nsNSAIDs
Non-interventional: Treatment assignment as per treating physician's judgement
|
Ages Eligible for Study: | 2 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191344 |
Study First Received: | May 29, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00688545 |
Health Authority: | United States: Food and Drug Administration |
Celecoxib, COX-2, NSAIDs, observational study, noninterventional study, cohort study, registry, epidemiologic study, pediatrics, rheumatology, phase iv study |
Celecoxib Autoimmune Diseases Arthritis, Juvenile Rheumatoid Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Anti-Inflammatory Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |