Rheumatoid Arthritis Clinical Trial
Official title:
Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's
The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study
designed to compare the cardiovascular safety of celecoxib versus traditional non-selective
Non Steroidal Anti-Inflammatory Drug (NSAID) therapy.Traditional NSAID's are associated with
significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2
(Cox-2)selective agents are associated with reduced upper gastrointestinal
toxicity.Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular
and renal disorders. Data from both randomised and observational studies suggest that
celecoxib has similar or reduced cardiovascular toxicity when compared to traditional
NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a
strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has
requested that studies of the cardiovascular safety of celecoxib be carried out within the
indicated population of Europe. This study addresses these issues by comparing the
cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of
the EU healthcare system.
As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of
follow up by the end of May 2014.
Aims
The present proposal seeks to compare the cardiovascular and gastrointestinal safety and
effectiveness of a strategy of initial randomisation to treatment with the selective COX-2
inhibitor celecoxib or to 'usual-care' with their current non-selective NSAID therapy (with
or without cyto-protection with ulcer healing drug use in either celecoxib or 'usual-care'
limbs).
Trial Design
This trial utilises the Prospective Randomised Open Blinded End point (PROBE) design .
Patients with clinically diagnosed osteoarthritis (OA) or rheumatoid arthritis (RA) 60 years
of age or more who are free from established cardiovascular disease and who require chronic
NSAID therapy will be identified in the setting of primary care. Patients will be randomised
to receive either celecoxib or to continue their previous standard NSAID therapy. They will
then be followed up for an average of 4.2 years in the setting of the local National
Healthcare system. The study will terminate when 277 adjudicated cardiovascular events have
accrued. A summary is shown in the diagram below.
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