Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthritis, Juvenile Rheumatoid
Intervention: Celecoxib (Drug); nsNSAIDs (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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).
Clinical Details
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 design: Cohort, Prospective
Primary outcome: General Safety
Secondary outcome: disease activity, growth outcomes
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2009
Ending date: December 2014
Last updated: September 26, 2008
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