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TARGET GCAT Registry

NCT04049071 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2021-05-12

No results posted yet for this study

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.

Conditions

  • Giant Cell Arteritis

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • University of Leeds

    lead OTHER

Principal Investigators

  • Ann Morgan · University of Leeds

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-13
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049071 on ClinicalTrials.gov