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Shorter steroid course may be just as effective for giant cell arteritis

NCT ID NCT04012905

Disease control Sponsor: University Hospital, Caen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether a shorter, lighter course of corticosteroids (28 weeks) works as well as the standard longer course (52 weeks) for giant cell arteritis, a condition that inflames blood vessels. The study aims to reduce side effects from long-term steroid use. 150 newly diagnosed patients will be randomly assigned to one of the two tapering schedules and followed for a year.

What this could mean

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

Active substance
Corticosteroids (prednisone)
What this could lead to
If successful, this could show that a shorter course of steroids works just as well as a longer one, reducing side effects for patients with giant cell arteritis.
What could go wrong
This is a relatively small trial (150 people) and only compares two steroid tapering schedules, not a new treatment. The shorter course may lead to more relapses.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

May 2029

An estimate. End dates often move.

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.

Ages

50 years and older

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 * Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given : * a temporal artery biopsy compatible with a diagnosis of CAG or * an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or * Echo Doppler compatible with a diagnosis of CAG * Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg / Kg * Patient wo has given its written consent Patient affiliated with a social security Exclusion Criteria: Subjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include: * Early treatment of CAG disease with a dose\> 1 mg / kg whatever the duration * Corticosteroids already started over 14 days * Giant arteritis cell on relapse * dementia syndrome * No compliant patient * Patients who live more than 150 km from the investigation center * Person under judicial protection, guardianship * Hypersensitivity to prednisone or any of its excipients * Infection requiring an systemic treatment * Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus) * Immunization with live vaccines / mitigated during the 8 weeks preceding inclusion * Pregnancy, breastfeeding women or women of childbearing potential not using contraception

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis Recurrence temporal arteritis

As listed by the trial registrant

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

Giant cell arteritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU de Caen Normandie

    RECRUITING

    Caen, 14000, France

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