The Standard Care Versus Celecoxib Outcome Trial

Rheumatoid Arthritis Clinical Trial

— SCOTLSSS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447759
• Other study ID #: SCOT Trial
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: August 2015

Study information

• Verified date: May 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7297
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Drug:
• Celecoxib
200-400mg daily in divided doses
• Diclofenac
prescribed medication taken orally

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense
Netherlands	Julius Clinical Research	Zeist
United Kingdom	University of Aberdeen	Aberdeen
United Kingdom	University of Birmingham	Birmingham
United Kingdom	University of Dundee	Dundee
United Kingdom	University of Edinburgh	Edinburgh
United Kingdom	University of Glasgow	Glasgow
United Kingdom	NHS Highlands	Inverness
United Kingdom	University of Nottingham	Nottingham
United Kingdom	University of Oxford	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	University of Glasgow, University of Nottingham

Countries where clinical trial is conducted

Denmark,  Netherlands,  United Kingdom, 

References & Publications (1)

MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.		4 years
Secondary	demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.		4 years

External Links

•   MEMO website
•   SCOT study website