The Standard Care Versus Celecoxib Outcome Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's

Conditions
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Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Diclofenac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 60 years or over Male & Female Chronic NSAIDs use for 90 days or more in a 12 month period Subjects who have a licensed indication for chronic non-selective NSAID or Celecoxib. Eligible for treatment with either Celecoxib or alternative traditional non-selective NSAID. Subjects who are willing to consent to their paper and electronic medical records and prescribing data to be accessed. Subjects who are willing to be contacted and interviewed by trial investigators. Exclusion Criteria: Established cardiovascular disease including ischaemic heart disease, Myocardial Infarction, angina or acute coronary syndrome, cerebrovascular disease or cerebrovascular accident or transient ischaemic attack, established peripheral vascular disease and moderate to severe heart failure.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomised Open Blinded-Endpoint Study (PROBE)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib<br>Celecoxib. Celebrex 200-400mg daily in divided doses | Drug: Celecoxib<br>* 200-400mg daily in divided doses<br>* Other names: Celebrex;|
| Active Comparator: Diclofenac<br>continue usual nsNSAID | Drug: Diclofenac<br>* prescribed medication taken orally<br>* Other names: other presribed sNSAIDs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthritis, Celecoxib, Celebrex, Ibuprofen, Diclofenac, NSAID, Osteoarthritis, Rheumatoid Arthritis, Safety study, Cardiovascular safety, Clinical trial, PROBE design, University of Dundee, Medicines Monitoring Unit, MEMO, Professor Tom MacDonald