Status:
TERMINATED
Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Arthritis, Juvenile Rheumatoid
Eligibility:
All Genders
2-17 years
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 prac...
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 chr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00688545
Start Date
April 1 2009
End Date
January 1 2012
Last Update
February 2 2021
Active Locations (27)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
2
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72202
3
Pfizer Investigational Site
Washington D.C., District of Columbia, United States, 20010
4
Pfizer Investigational Site
Arlington Heights, Illinois, United States, 60005