Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00688545

Purpose

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

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Primary Outcome Measures:

General Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

disease activity, growth outcomes [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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	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

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
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).

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688545

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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

Keywords provided by Pfizer:

Celecoxib, COX-2, NSAIDs, observational study, noninterventional study, cohort study, registry, epidemiologic study, pediatrics, rheumatology, phase iv study

Study placed in the following topic categories:

Celecoxib
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on January 16, 2009