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Trial record 20 of 130 for:    GCA

TARGET GCAT Registry

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ClinicalTrials.gov Identifier: NCT04049071
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborators:
University of Oxford
Hoffmann-La Roche
Information provided by (Responsible Party):
Ann Morgan, University of Leeds

Brief 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. 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.


Condition or disease
Giant Cell Arteritis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 18 Months
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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To determine the proportion of eligible patients who achieve a sustained 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

  2. 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 ]
    Collection of safety data throughout study (non serious adverse events, serious adverse events, adverse events of special interest, special situations, notification of death)

  3. 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 ]
    All data collected throughout the study period

  4. 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 ]
    Data on disease features and lab tests collected at month 12 and 18 and compared with that collected at baseline and month 6

  5. 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 ]
    Data collected on disease features, inflammatory markers and vital signs.

  6. 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 ]
    Data collected on disease features and event reporting as appropriate (serious adverse events & non-serious adverse events).

  7. 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 ]
    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.

  8. 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 ]
    Data on glucocorticoid collected throughout study including dose changes & date of change

  9. To describe reasons for premature discontinuation of tocilizumab [ Time Frame: 0-18 months ]
    Reason for premature discontinuation of tocilizumab is captured at the follow up visits.

  10. 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 ]
    Data collected throughout study on features associated with glucocorticoid toxicity such as those listed within the title

  11. 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 ]
    Keeping a record of those who have been agreed to be contacted for similar studies in the randomised controlled trials



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500 patients prescribed tocilizumab for GCA within the NHS and 500 age-, sex- and centre-matched controls.
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049071


Contacts
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Contact: Rachael Kearns 0113 343 7764 MRCTarget@leeds.ac.uk
Contact: Kim Atkinson 0113 343 7764 MRCTarget@leeds.ac.uk

Locations
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United Kingdom
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Asad Khan         
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom
Contact: Poonam Sharma         
Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust Not yet recruiting
Derby, United Kingdom
Contact: Lit Hiang Lee         
Ninewells Hospital and Medical School, NHS Tayside Not yet recruiting
Dundee, United Kingdom
Contact: Smita Bhat         
NHS Lothian, Edinburgh Not yet recruiting
Edinburgh, United Kingdom
Contact: Neil McKay         
Inverclyde Royal Hospital, NHS Greater Glasgow & Clyde Not yet recruiting
Glasgow, United Kingdom
Contact: Lisa Hutton         
Royal Alexandra Hospital, NHS Greater Glasgow & Clyde Not yet recruiting
Glasgow, United Kingdom
Contact: Martin Perry         
Vale of Leven Hospital, NHS Greater Glasgow & Clyde Not yet recruiting
Glasgow, United Kingdom
Contact: Martin Perry         
Harrogate and District NHS Foundation Trust Recruiting
Harrogate, United Kingdom
Contact: Cathy Lawson         
Airedale General Hospital, Airedale NHS Foundation Trust Recruiting
Keighley, United Kingdom
Contact: Shabina Sultan         
Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust Not yet recruiting
Kendal, United Kingdom
Contact: Marwan Bukhari         
Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust Recruiting
Leeds, United Kingdom
Contact: Sarah Mackie         
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust Not yet recruiting
Leicester, United Kingdom
Contact: Kehinde O'Sunmboye         
Aintree University Hospital, Aintree University Hospital NHS Foundation Trust Not yet recruiting
Liverpool, United Kingdom
Contact: Robert Moots         
Royal Glamorgan Hospital, Cwm Taf University Health Board Recruiting
Llantrisant, United Kingdom
Contact: Ceril Rhys Dillon         
Kings College Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Eoin O'sullivan         
Royal Free Hospital, Royal Free London NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Animesh Singh         
University College London NHS Foundation Trust Not yet recruiting
London, United Kingdom
Contact: Vanessa Morris         
Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust Not yet recruiting
Luton, United Kingdom
Contact: Vanessa Quick         
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom
Contact: Eoghan McCarthy         
The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle Upon Tyne, United Kingdom
Contact: John Isaacs         
Northampton General Hospital Recruiting
Northampton, United Kingdom
Contact: Pradip Nandi         
Norfolk and Norwich University Hospital NHS Foundation Trust Not yet recruiting
Norwich, United Kingdom
Contact: Chetan Mukhtyar         
Queens Medical Centre, Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Peter Lanyon         
Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust Not yet recruiting
Oxford, United Kingdom
Contact: Raashid Luqmani         
Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust Recruiting
Preston, United Kingdom
Contact: Hedley Emsley         
Southend University Hospital NHS Foundation Trust Not yet recruiting
Southend-on-Sea, United Kingdom
Contact: Bhaskar Dasgupta         
Lister Hospital, East and North Hertfordshire NHS Trust Not yet recruiting
Stevenage, United Kingdom
Contact: Thiraupathy Marianayagam         
Torbay Hospital, Torbay and South Devon NHS Foundation Trust Recruiting
Torquay, United Kingdom
Contact: Kirsten Mackay         
Royal Cornwall Hospitals NHS Foundation Trust Recruiting
Truro, United Kingdom
Contact: David Hutchinson         
Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust Not yet recruiting
Wakefield, United Kingdom
Contact: Gayle Smithson         
Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust Not yet recruiting
Wakefield, United Kingdom
Contact: Gayle Smithson         
University Hospital Wishaw, NHS Lanarkshire Not yet recruiting
Wishaw, United Kingdom
Contact: James Dale         
York Teaching Hospital NHS Foundation Trust Recruiting
York, United Kingdom
Contact: Michael Green         
Sponsors and Collaborators
University of Leeds
University of Oxford
Hoffmann-La Roche
Investigators
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Principal Investigator: Ann Morgan University of Leeds

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Responsible Party: Ann Morgan, Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist, University of Leeds
ClinicalTrials.gov Identifier: NCT04049071     History of Changes
Other Study ID Numbers: MM05/7307
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ann Morgan, University of Leeds:
Tocilizumab
Giant Cell Arteritis
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases