OsteoarthritisPhase 4SCOTLSSSNCT00447759
The Standard Care Versus Celecoxib Outcome Trial
A Phase 4 study testing Celecoxib and Diclofenac in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Dundee at 10 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis
- What is being tested?
- Celecoxib and Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,297 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jun 2007to Aug 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United Kingdom8 sites
University of Aberdeen
Aberdeen, AB25 2ZN
University of Birmingham
Birmingham, B15 2TT
University of Dundee
Dundee, DD1 9SY
University of Edinburgh
Edinburgh, EH4 2XU
University of Glasgow
Glasgow, G11 6NT
NHS Highlands
Inverness, IV2 3JH
University of Nottingham
Nottingham, NG7 2UH
University of Oxford
Oxford, OX1 2ET
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Being tested
- Celecoxib, Diclofenac
- Keywords
- Celecoxib, Celebrex, Ibuprofen, Diclofenac, NSAID, Osteoarthritis, Rheumatoid Arthritis, Arthritis, Safety study, Cardiovascular safety, Clinical trial, PROBE design, University of Dundee, Medicines Monitoring Unit, MEMO, Professor Tom MacDonald
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
200-400mg daily in divided doses
DiclofenacDrug
Also called Ibuprofen, Naproxen, meloxicam, other presribed sNSAIDs
prescribed medication taken orally
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Experimental | Celecoxib. Celebrex 200-400mg daily in divided doses Receives: Drug: Celecoxib |
| Diclofenac | Active comparator | continue usual nsNSAID Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
Measured: 4 years
Secondary outcomes (1)
demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomised Open Blinded-Endpoint Study (PROBE)
- Masking
- None (open label)
- Enrolment
- 7,297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Thomas M MacDonald, MD MRCP FRCP, Principal investigator, University of DundeeIan Ford, FRCP FRSE, Principal investigator, University of GlasgowChristopher J Hawkey, MRCP DM FRC, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447759
- Sponsor's protocol ID
- SCOT Trial
- Acronym
- SCOTLSSS
- Status last verified
- May 2019
- First submitted
- 14 Mar 2007
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data released on application to steering committee
Publications
MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7. doi: 10.1097/00005344-200605001-00017.
PubMed 16785838MacDonald TM, Hawkey CJ, Ford I, McMurray JJV, Scheiman JM, Hallas J, Findlay E, Grobbee DE, Hobbs FDR, Ralston SH, Reid DM, Walters MR, Webster J, Ruschitzka F, Ritchie LD, Perez-Gutthann S, Connolly E, Greenlaw N, Wilson A, Wei L, Mackenzie IS. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J. 2017 Jun 14;38(23):1843-1850. doi: 10.1093/eurheartj/ehw387.
PubMed 27705888Jennings CG, MacDonald TM, Wei L, Brown MJ, McConnachie L, Mackenzie IS. Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015 Mar 7;16:80. doi: 10.1186/s13063-015-0582-8.
PubMed 25888477Macdonald TM, Mackenzie IS, Wei L, Hawkey CJ, Ford I; SCOT study group collaborators. Methodology of a large prospective, randomised, open, blinded endpoint streamlined safety study of celecoxib versus traditional non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis: protocol of the standard care versus celecoxib outcome trial (SCOT). BMJ Open. 2013 Jan 29;3(1):e002295. doi: 10.1136/bmjopen-2012-002295.
PubMed 23364320
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's
- ClinicalTrials.gov ID
- NCT00447759
- Acronym / sponsor ID
- SCOTLSSS / SCOT Trial
- Conditions
- Osteoarthritis, Rheumatoid Arthritis
- Keywords
- Celecoxib, Celebrex, Ibuprofen, Diclofenac, NSAID, Osteoarthritis, Rheumatoid Arthritis, Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,297 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- University of Glasgow, University of Nottingham
- Study start
- Jun 2007
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomised Open Blinded-Endpoint Study (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibCelecoxib. Celebrex 200-400mg daily in divided doses |
| Diclofenac | Active comparator | Drug: Diclofenaccontinue usual nsNSAID |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: Celebrex200-400mg daily in divided doses | Drug | Celecoxib |
| DiclofenacAlso: Ibuprofen, Naproxen, meloxicam, other presribed sNSAIDsprescribed medication taken orally | Drug | Diclofenac |
Primary outcome
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
Time frame: 4 years
1 secondary outcome
demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Background: PubMed 16785838MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7. doi: 10.1097/00005344-200605001-00017.
- Derived from this study: PubMed 27705888MacDonald TM, Hawkey CJ, Ford I, McMurray JJV, Scheiman JM, Hallas J, Findlay E, Grobbee DE, Hobbs FDR, Ralston SH, Reid DM, Walters MR, Webster J, Ruschitzka F, Ritchie LD, Perez-Gutthann S, Connolly E, Greenlaw N, Wilson A, Wei L, Mackenzie IS. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J. 2017 Jun 14;38(23):1843-1850. doi: 10.1093/eurheartj/ehw387.
- Derived from this study: PubMed 25888477Jennings CG, MacDonald TM, Wei L, Brown MJ, McConnachie L, Mackenzie IS. Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015 Mar 7;16:80. doi: 10.1186/s13063-015-0582-8.
- Derived from this study: PubMed 23364320Macdonald TM, Mackenzie IS, Wei L, Hawkey CJ, Ford I; SCOT study group collaborators. Methodology of a large prospective, randomised, open, blinded endpoint streamlined safety study of celecoxib versus traditional non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis: protocol of the standard care versus celecoxib outcome trial (SCOT). BMJ Open. 2013 Jan 29;3(1):e002295. doi: 10.1136/bmjopen-2012-002295.
- Individual participant dataSharing planned: Yes. Data released on application to steering committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M MacDonald, MD MRCP FRCP principal investigator
University of Dundee
Ian Ford, FRCP FRSE principal investigator
University of Glasgow
Christopher J Hawkey, MRCP DM FRC principal investigator
University of Nottingham
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Celecoxib and Diclofenac in people with Osteoarthritis and Rheumatoid Arthritis, run by University of Dundee at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.