TARGET GCAT Registry

• Sponsor: University of Leeds (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04049071
• Collaborator: University of Oxford (Other), Hoffmann-La Roche (Industry)
• Enrollment: 80
• Locations: 34
• Actual Duration (Months): 13.6
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Intervention/Treatment	Phase
Giant Cell Arteritis

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Primary Completion Date: Jun 30, 2020
• Actual Study Completion Date: Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

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 [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 [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. [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. [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 [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 [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 [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 [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 [0-18 months]

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

9. To describe reasons for premature discontinuation of tocilizumab [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 [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 [0-18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust	Birmingham		United Kingdom
2	Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust	Cambridge		United Kingdom
3	Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust	Derby		United Kingdom
4	Ninewells Hospital and Medical School, NHS Tayside	Dundee		United Kingdom
5	NHS Lothian, Edinburgh	Edinburgh		United Kingdom
6	Inverclyde Royal Hospital, NHS Greater Glasgow & Clyde	Glasgow		United Kingdom
7	Royal Alexandra Hospital, NHS Greater Glasgow & Clyde	Glasgow		United Kingdom
8	Vale of Leven Hospital, NHS Greater Glasgow & Clyde	Glasgow		United Kingdom
9	Harrogate and District NHS Foundation Trust	Harrogate		United Kingdom
10	Airedale General Hospital, Airedale NHS Foundation Trust	Keighley		United Kingdom
11	Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust	Kendal		United Kingdom
12	Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust	Leeds		United Kingdom
13	Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust	Leicester		United Kingdom
14	Aintree University Hospital, Aintree University Hospital NHS Foundation Trust	Liverpool		United Kingdom
15	Royal Glamorgan Hospital, Cwm Taf University Health Board	Llantrisant		United Kingdom
16	Kings College Hospital NHS Foundation Trust	London		United Kingdom
17	Royal Free Hospital, Royal Free London NHS Foundation Trust	London		United Kingdom
18	University College London NHS Foundation Trust	London		United Kingdom
19	Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust	Luton		United Kingdom
20	Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust	Manchester		United Kingdom
21	The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne		United Kingdom
22	Northampton General Hospital	Northampton		United Kingdom
23	Norfolk and Norwich University Hospital NHS Foundation Trust	Norwich		United Kingdom
24	Queens Medical Centre, Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom
25	Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom
26	Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust	Preston		United Kingdom
27	Southend University Hospital NHS Foundation Trust	Southend-on-Sea		United Kingdom
28	Lister Hospital, East and North Hertfordshire NHS Trust	Stevenage		United Kingdom
29	Torbay Hospital, Torbay and South Devon NHS Foundation Trust	Torquay		United Kingdom
30	Royal Cornwall Hospitals NHS Foundation Trust	Truro		United Kingdom
31	Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust	Wakefield		United Kingdom
32	Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust	Wakefield		United Kingdom
33	University Hospital Wishaw, NHS Lanarkshire	Wishaw		United Kingdom
34	York Teaching Hospital NHS Foundation Trust	York		United Kingdom

Sponsors and Collaborators

• University of Leeds
• University of Oxford
• Hoffmann-La Roche

Investigators

• Principal Investigator: Ann Morgan, University of Leeds

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ann Morgan, Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist, University of Leeds
• ClinicalTrials.gov Identifier: NCT04049071
• Other Study ID Numbers: MM05/7307
• First Posted: Aug 7, 2019
• Last Update Posted: May 12, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ann Morgan, Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist, University of Leeds: Tocilizumab; Giant Cell Arteritis
• Additional relevant MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis

Study Results

No Results Posted as of May 12, 2021