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Which drug protects the heart better in giant cell arteritis?

NCT ID NCT07459335

Knowledge-focused Sponsor: Groupe français d'étude des Maladies Inflammatoires de loeil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at over 1,600 people with giant cell arteritis, a condition that inflames blood vessels and raises heart risks. Researchers compared tocilizumab and methotrexate to see which better prevents heart attacks, strokes, or death. Using French health data, they analyzed real-world outcomes to guide treatment choices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab and methotrexate
What this could lead to
If this study shows one drug is better, it could guide doctors to choose the safer option for heart health in giant cell arteritis patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,667 people

The number who actually took part.

Started

Jan 2012

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients aged ≥50 years hospitalized for incident giant cell arteritis in France identified from the SNDS database.

Ages

50 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥50 years Incident hospitalization for giant cell arteritis Initiation of tocilizumab or methotrexate within 6 months Received systemic corticosteroids ≥20 mg/day within 30 days following hospital discharge Exclusion Criteria: * Prior use of tocilizumab or methotrexate Age \>90 years Length of stay \>30 days Not discharged home Prior aortic disease or vascular imaging within 2 years Initiation of both treatments during grace period

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Giant Cell Arteritis temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Giant cell arteritis (GCA)

Contacts and locations

Locations

  • APHP_ Hôpital Pitié-Salpêtrière

    Paris, 75013, France

  • APHP_ Hôpital Saint-Antoine

    Paris, 75012, France

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