TARGET GCAT Registry

University of Leeds

Status: Terminated

Conditions: Giant Cell Arteritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04049071

MM05/7307

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

80 participants in 2 patient groups

Case

Description:

Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA

Control

Description:

Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA.