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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Celecoxib

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	November 2011 (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

Locations

United States, Arizona
Pfizer Investigational Site	Recruiting
Phoenix, Arizona, United States, 85006
United States, Arkansas
Pfizer Investigational Site	Recruiting
Little Rock, Arkansas, United States, 72202
United States, District of Columbia
Pfizer Investigational Site	Recruiting
Washington, District of Columbia, United States, 20010
United States, Illinois
Pfizer Investigational Site	Recruiting
Chigcago, Illinois, United States, 60637
United States, New Jersey
Pfizer Investigational Site	Recruiting
Livingston, New Jersey, United States, 07039
Pfizer Investigational Site	Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Pfizer Investigational Site	Recruiting
Brooklyn, New York, United States, 11211
Pfizer Investigational Site	Recruiting
Brooklyn, New York, United States, 11214
Pfizer Investigational Site	Recruiting
Commack, New York, United States, 11725
Pfizer Investigational Site	Recruiting
New Hyde Park, New York, United States, 11040
Pfizer Investigational Site	Recruiting
Great Neck, New York, United States, 11021
Pfizer Investigational Site	Recruiting
Nyc, New York, United States, 10016
United States, North Carolina
Pfizer Investigational Site	Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site	Recruiting
Cincinnati, Ohio, United States, 45229-3026
Pfizer Investigational Site	Recruiting
Liberty Township, Ohio, United States, 45044
Pfizer Investigational Site	Not yet recruiting
Cleveland, Ohio, United States, 44106
United States, Texas
Pfizer Investigational Site	Recruiting
Austin, Texas, United States, 78723

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3191344
Study First Received:	May 29, 2008
Last Updated:	February 5, 2010
ClinicalTrials.gov Identifier:	NCT00688545 History of Changes
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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Celecoxib
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Arthritis, Rheumatoid
Enzyme Inhibitors
Rheumatic Diseases

Pharmacologic Actions
Musculoskeletal Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010