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Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

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Summary

An observational clinical study (NCT07552636) registered on ClinicalTrials.gov evaluating tools for monitoring disease activity and predicting relapses in patients with Giant Cell Arteritis (GCA). The study will enroll up to 175 patients with GCA in remission, with a target of 144 participants completing 1 year of follow-up. Participants will undergo vascular ultrasonography with double-blinded relapse assessment, complete patient-reported outcome measures, and provide biobank blood samples.

“Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up.”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

A new observational clinical trial registration for Giant Cell Arteritis (GCA) disease activity monitoring has been posted to ClinicalTrials.gov. The study aims to evaluate tools that assist in monitoring disease activity and predicting future relapses and higher treatment requirements in patients with GCA in remission, with a focus on addressing limitations of conventional inflammatory markers in patients receiving IL-6 pathway-targeting therapies.

Healthcare providers and clinical investigators involved in vasculitis research may find this study relevant for understanding emerging monitoring approaches. The study's target enrollment of 175 patients with 144 completers over 1 year, combined with vascular ultrasonography and biobank sample collection, represents a substantive investment in GCA clinical research infrastructure.

Archived snapshot

Apr 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Disease Activity Monitoring in Patients With Giant Cell Arteritis Study

Observational NCT07552636 Kind: OBSERVATIONAL Apr 27, 2026

Abstract

Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the IL-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and/or predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.

Conditions: Giant Cell Arteritis (GCA)

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial Observational study
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals

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