Giant Cell ArteritisNCT04049071
TARGET GCAT Registry
An observational study of Giant Cell Arteritis, run by University of Leeds at 34 sites in United Kingdom.
Trial summary
A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- How many people
- 80 participants
- Where
- 34 sitesUnited Kingdom
- Study dates
- 13 May 2019to 30 Jun 2020
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 patients prescribed tocilizumab for GCA within the NHS and 500 age-, sex- and centre-matched controls.
Who may be able to join
- Patient must have a diagnosis of GCA and be eligible for the UK GCA Consortium study
- Willing and able to consent
- Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
- Require treatment escalation
Who cannot join
None listed.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United Kingdom34 sites
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
Birmingham
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge
Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust
Derby
Ninewells Hospital and Medical School, NHS Tayside
Dundee
NHS Lothian, Edinburgh
Edinburgh
Inverclyde Royal Hospital, NHS Greater Glasgow & Clyde
Glasgow
Royal Alexandra Hospital, NHS Greater Glasgow & Clyde
Glasgow
Vale of Leven Hospital, NHS Greater Glasgow & Clyde
Glasgow
Harrogate and District NHS Foundation Trust
Harrogate
Airedale General Hospital, Airedale NHS Foundation Trust
Keighley
Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal
Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust
Leeds
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester
Aintree University Hospital, Aintree University Hospital NHS Foundation Trust
Liverpool
Royal Glamorgan Hospital, Cwm Taf University Health Board
Llantrisant
Kings College Hospital NHS Foundation Trust
London
Royal Free Hospital, Royal Free London NHS Foundation Trust
London
University College London NHS Foundation Trust
London
Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust
Luton
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester
The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
Northampton General Hospital
Northampton
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
Queens Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham
Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
Oxford
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Southend University Hospital NHS Foundation Trust
Southend-on-Sea
Lister Hospital, East and North Hertfordshire NHS Trust
Stevenage
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay
Royal Cornwall Hospitals NHS Foundation Trust
Truro
Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield
Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust
Wakefield
University Hospital Wishaw, NHS Lanarkshire
Wishaw
York Teaching Hospital NHS Foundation Trust
York
About this study
Official title: Proposal for Establishment of a UK Post-marketing Surveillance Registry to Study the Effectiveness, Safety and Prescribing Habits of Tocilizumab for the Treatment of Giant Cell Arteritis in the UK National Health Service, Nested Within the Existing Structure of the UK GCA Consortium and UKIVAS Studies
A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Half the patients recruited will have been prescribed tocilizumab (cases) and the other half will be prescribed alternative therapies (controls).
There are four study visits over 18 months: baseline, 6 months, 12 months and 18 months. At each visit data is collected on demographics; diagnosis and investigations; previous and concomitant medications; medical history; co-morbidities, vital signs; smoking and alcohol; disease activity and damage; routine laboratory tests; reason for starting escalation therapy. Safety data is collected on an ongoing basis.
- Conditions
- Giant Cell Arteritis
- Keywords
- Tocilizumab, Giant Cell Arteritis
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA | |
| Control | Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
Data on disease features and lab tests collected at 6 month, compared with that collected at baseline
Measured: 6 months
Secondary outcomes (11)
To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab
Data on disease features and lab tests collected at 6 month, compared with that collected at baseline
Measured: 6 months
To assess the safety (event reporting) and effectiveness (in terms of prevention of relapse) of tocilizumab compared to other strategies for refractory/relapsing disease in patients with GCA who require escalation therapy.
Collection of safety data throughout study (non serious adverse events, serious adverse events, adverse events of special interest, special situations, notification of death)
Measured: 18 months
To compare characteristics (demographics, disease severity, risk factors for steroid toxicity, contraindications to tocilizumab, concomitant medications) of real-world patients prescribed tocilizumab to clinical trial populations.
All data collected throughout the study period
Measured: 0-18 months
To describe relapse rates in patients with GCA treated with tocilizumab at treatment completion (usually 12 months in the UK) and 6 months following discontinuation of tocilizumab
Data on disease features and lab tests collected at month 12 and 18 and compared with that collected at baseline and month 6
Measured: 0-18 months
To describe disease activity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Data collected on disease features, inflammatory markers and vital signs.
Measured: 0-12 months
To describe ischaemic complications during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Data collected on disease features and event reporting as appropriate (serious adverse events \& non-serious adverse events).
Measured: 0-12 months
To describe drug related toxicity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Data collected on lab results such as HbA1c and medication taken including the dose, reason for changes in dose or discontinuation, documentation of any events relating to drug toxicity.
Measured: 0-12 months
To describe patterns of glucocorticoid dosing, including estimated cumulative dose & time to discontinuation of glucocorticoids, in patients with GCA & treated with tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Data on glucocorticoid collected throughout study including dose changes \& date of change
Measured: 0-18 months
To describe reasons for premature discontinuation of tocilizumab
Reason for premature discontinuation of tocilizumab is captured at the follow up visits.
Measured: 0-18 months
To estimate the prevalence of glucocorticoid toxicity (e.g. weight gain, fracture, diabetes, infection, or new psychiatric diagnosis) in patients with GCA who are treated with tocilizumab, compared to other strategies for refractory/relapsing disease
Data collected throughout study on features associated with glucocorticoid toxicity such as those listed within the title
Measured: 0-18 months
To invite patients who agree to take part in the current study to consent to being approached to participate in future related studies of their condition, including randomised controlled trials
Keeping a record of those who have been agreed to be contacted for similar studies in the randomised controlled trials
Measured: 0-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start13 May 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Covid-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Hoffmann-La Roche
- Responsible party
- Principal investigator, Ann Morgan, University of Leeds
- Investigators
- Ann Morgan, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049071
- Sponsor's protocol ID
- MM05/7307
- Status last verified
- May 2021
- First submitted
- 5 Aug 2019
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Establishment of a UK Post-marketing Surveillance Registry to Study the Effectiveness, Safety and Prescribing Habits of Tocilizumab for the Treatment of Giant Cell Arteritis in the UK National Health Service, Nested Within the Existing Structure of the UK GCA Consortium and UKIVAS Studies
- ClinicalTrials.gov ID
- NCT04049071
- Acronym / sponsor ID
- MM05/7307
- Conditions
- Giant Cell Arteritis
- Keywords
- Tocilizumab, Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Covid-19
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- University of Oxford, Hoffmann-La Roche
- Study start
- 13 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- 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.
A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Half the patients recruited will have been prescribed tocilizumab (cases) and the other half will be prescribed alternative therapies (controls).
There are four study visits over 18 months: baseline, 6 months, 12 months and 18 months. At each visit data is collected on demographics; diagnosis and investigations; previous and concomitant medications; medical history; co-morbidities, vital signs; smoking and alcohol; disease activity and damage; routine laboratory tests; reason for starting escalation therapy. Safety data is collected on an ongoing basis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA |
| Control | – | –Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients prescribed tocilizumab for GCA within the NHS and 500 age-, sex- and centre-matched controls.
Key inclusion criteria (4 listed)
- Patient must have a diagnosis of GCA and be eligible for the UK GCA Consortium study
- Willing and able to consent
- Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
- Require treatment escalation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
Time frame: 6 months
Data on disease features and lab tests collected at 6 month, compared with that collected at baseline
11 secondary outcomes
To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab
Time frame: 6 months
To assess the safety (event reporting) and effectiveness (in terms of prevention of relapse) of tocilizumab compared to other strategies for refractory/relapsing disease in patients with GCA who require escalation therapy.
Time frame: 18 months
To compare characteristics (demographics, disease severity, risk factors for steroid toxicity, contraindications to tocilizumab, concomitant medications) of real-world patients prescribed tocilizumab to clinical trial populations.
Time frame: 0-18 months
To describe relapse rates in patients with GCA treated with tocilizumab at treatment completion (usually 12 months in the UK) and 6 months following discontinuation of tocilizumab
Time frame: 0-18 months
To describe disease activity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Time frame: 0-12 months
To describe ischaemic complications during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Time frame: 0-12 months
To describe drug related toxicity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Time frame: 0-12 months
To describe patterns of glucocorticoid dosing, including estimated cumulative dose & time to discontinuation of glucocorticoids, in patients with GCA & treated with tocilizumab, compared to other treatment strategies for refractory/relapsing disease
Time frame: 0-18 months
To describe reasons for premature discontinuation of tocilizumab
Time frame: 0-18 months
To estimate the prevalence of glucocorticoid toxicity (e.g. weight gain, fracture, diabetes, infection, or new psychiatric diagnosis) in patients with GCA who are treated with tocilizumab, compared to other strategies for refractory/relapsing disease
Time frame: 0-18 months
To invite patients who agree to take part in the current study to consent to being approached to participate in future related studies of their condition, including randomised controlled trials
Time frame: 0-18 months
Results and safety
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
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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.
Ann Morgan principal investigator
University of Leeds
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by University of Leeds at 34 sites in United Kingdom.
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 4 inclusion and 0 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: stopped early, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United Kingdom. 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.
Are results available for this study?
The study was stopped early (reason given: Covid-19). Results are not available in the source record.
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?
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2021.