Clinical trial NCT00688545: Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Celecoxib
COX-2
NSAIDs
observational study
noninterventional study
cohort study
registry
epidemiologic study
pediatrics
rheumatology
phase iv study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 275
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

Brief 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).

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 2 years
measure: JIA Concomitant Medications
timeFrame: Year 2 or early termination
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Arlington Heights
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Glenview
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: New Lenox
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Westchester
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Hackensack
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Livingston
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: Commack
country: United States
facility: Pfizer Investigational Site
state: New York
city: Great Neck
country: United States
facility: Pfizer Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Liberty Township
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Strongsville
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sobel RE, Lovell DJ, Brunner HI, Weiss JE, Morris PW, Gottlieb BS, Chalom EC, Jung LK, Onel KB, Petiniot L, Goldsmith DP, Nanda K, Shishov M, Abramsky S, Young JP, Giannini EH; Pediatric Rheumatology Collaborative Study Group. Safety of celecoxib and nonselective nonsteroidal anti-inflammatory drugs in juvenile idiopathic arthritis: results of the Phase 4 registry. Pediatr Rheumatol Online J. 2014 Jul 16;12:29. doi: 10.1186/1546-0096-12-29. eCollection 2014.