The Standard Care Versus Celecoxib Outcome Trial

Phase 4

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis
• Interventions: Drug: Celecoxib; Drug: Diclofenac

• Registration Number: NCT00447759
• Lead Sponsor: University of Dundee

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Study Start: 2007-06
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-01
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7297

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	Celecoxib. Celebrex 200-400mg daily in divided doses
Diclofenac	Diclofenac	continue usual nsNSAID

Primary Outcome Measures

Name	Time	Method
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.	4 years

Secondary Outcome Measures

Name	Time	Method
demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.	4 years

Trial Locations

Locations (10)

Julius Clinical Research; 🇳🇱 Zeist, Netherlands

University of Dundee; 🇬🇧 Dundee, United Kingdom

NHS Highlands; 🇬🇧 Inverness, United Kingdom

University of Birmingham; 🇬🇧 Birmingham, United Kingdom

University of Southern Denmark; 🇩🇰 Odense, Denmark

University of Glasgow; 🇬🇧 Glasgow, United Kingdom

University of Aberdeen; 🇬🇧 Aberdeen, United Kingdom

University of Oxford; 🇬🇧 Oxford, United Kingdom

University of Nottingham; 🇬🇧 Nottingham, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom