Trials / Terminated
TerminatedNCT00688545
Naturalistic Safety Registry Of Celecoxib (CELEBREX(R)) And NSAIDs In Juvenile Idiopathic Arthritis
SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 275 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Celecoxib | Non-interventional: Treatment assignment as per treating physician's judgement |
| DRUG | nsNSAIDs | Non-interventional: Treatment assignment as per treating physician's judgement |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2008-06-03
- Last updated
- 2021-02-02
- Results posted
- 2013-07-19
Locations
27 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00688545. Inclusion in this directory is not an endorsement.