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Could an extra year of Low-Dose steroids keep vasculitis at bay?

NCT ID NCT03290456

Disease control Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether continuing a low dose of prednisone (5 mg/day) for an extra 12 months can help people with a type of blood vessel inflammation called ANCA-associated vasculitis stay in remission. About 146 adults who are already in remission and receiving rituximab will be randomly assigned to either extended prednisone or a placebo. The goal is to see if the extended treatment reduces the chance of a relapse over 30 months.

What this could mean

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

Active substance
Prednisone (a corticosteroid drug)
What this could lead to
If it works, this could show that longer low-dose prednisone use reduces relapse risk in people with vasculitis who are already on rituximab maintenance therapy.
What could go wrong
This is a Phase NA trial with only 146 participants, so results may not apply to everyone. Prednisone has known side effects like weight gain, high blood sugar, and infection risk.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 146 people

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

Started

Aug 2019

Expected to finish

Oct 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

18 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: * Patients with a diagnosis of MPA or GPA independently of ANCA status, * Patient aged of 18 years or older, * Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an inactive disease defined as a BVAS = 0, * Patients receiving maintenance infusion of rituximab 500 mg at 6 and 12 months after the start of vasculitis induction * Patients receiving 5-10 mg/day of prednisone at screening, * Patient able to give written informed consent prior to participation in the study. * At Inclusion visit day, patient must be between 5 and 10 mg/day prednisone and at randomization visit day (D1), patient must be at 5 mg/day prednisone Exclusion Criteria: * Patients with EGPA, or other vasculitides, defined by the ACR criteria and/or the Chapel Hill Consensus Conference, * Patients with vasculitis with active disease defined as a BVAS \>0, * Patients with acute infections or chronic active infections (including HIV, HBV or HCV), * Patients with active cancer or recent cancer (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment, * Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the all duration of the study, * Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol, * Patients included in other investigational therapeutic study within the previous 3 months, * Patients suspected not to be observant to the proposed treatments, * Patients who have white blood cell count ≤4,000/mm3, * Patients who have platelet count ≤100,000/mm3, * Patients who have ALT or AST level greater than 3 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease, * Patients unable to give written informed consent prior to participation in the study. * Patients with contraindication to use rituximab,

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Conditions

The condition(s) this trial relates to.

granulomatosis with polyangiitis microscopic polyangiitis vasculitis

As listed by the trial registrant

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

Granulomatosis with polyangitis

How to take part

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

  1. The places running it

    45 sites. 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

  • CH Bretagne Atlantique

    RECRUITING

    Vannes, 56017, France

  • CH Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • CH Lyon Sud

    RECRUITING

    Pierre-Bénite, 69495, France

  • CH Valenciennes

    RECRUITING

    Valenciennes, 59322, France

  • CH de Troyes

    RECRUITING

    Troyes, 10003, France

  • CH de Verdun

    NOT_YET_RECRUITING

    Verdun, 55100, France

  • CHIC Créteil

    NOT_YET_RECRUITING

    Créteil, 94010, France

  • CHRU Bretonneau

    NOT_YET_RECRUITING

    Tours, 37044, France

  • CHRU François Mitterrand

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • CHRU François Mitterrand

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • CHRU Hautepierre

    NOT_YET_RECRUITING

    Strasbourg, 67098, France

  • CHRU Lille - Hôpital Claude Huriez

    NOT_YET_RECRUITING

    Lille, 59037, France

  • CHRU Rennes - Hôpital Sud

    RECRUITING

    Rennes, 35200, France

  • CHU Amiens-Hôpital Nord

    RECRUITING

    Amiens, 80054, France

  • CHU Angers

    RECRUITING

    Angers, 49933, France

  • CHU Estaing

    RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU Gabriel Montpied

    RECRUITING

    Clermont-Ferrand, 63003, France

  • CHU Nantes - Hôtel Dieu

    RECRUITING

    Nantes, 44093, France

  • CHU Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67000, France

  • CHU de Caen - Cote de Nacre

    RECRUITING

    Caen, 14033, France

  • CHU de Nice - Hôpital Pasteur 2

    RECRUITING

    Nice, 06001, France

  • CHU de Poitiers

    NOT_YET_RECRUITING

    Poitiers, 86021, France

  • Centre Hospitalier Croix Rousse

    RECRUITING

    Lyon, 69004, France

  • Centre Hospitalier Lyon Sud

    RECRUITING

    Pierre-Bénite, 69310, France

  • Clinique Rhône-Durance

    NOT_YET_RECRUITING

    Avignon, 84000, France

  • HP Site Belle Isle

    NOT_YET_RECRUITING

    Metz, 57045, France

  • Hopitaux Universaitaire de Strasbourg Hopitaux

    RECRUITING

    Strasbourg, France

  • Hôpital Avicenne

    NOT_YET_RECRUITING

    Bobigny, 93009, France

  • Hôpital Charles Nicolle

    RECRUITING

    Rouen, 76031, France

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Edouard Herriot

    RECRUITING

    Lyon, 69137, France

  • Hôpital Edouard Herriot

    NOT_YET_RECRUITING

    Lyon, 69137, France

  • Hôpital Européen G. Pompidou

    NOT_YET_RECRUITING

    Paris, 75015, France

  • Hôpital Foch

    NOT_YET_RECRUITING

    Suresnes, 92150, France

  • Hôpital Haut Lévêque

    NOT_YET_RECRUITING

    Pessac, 33600, France

  • Hôpital Jeanne d'Arc

    NOT_YET_RECRUITING

    Bar-le-Duc, 55000, France

  • Hôpital La Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • Hôpital La Timone

    NOT_YET_RECRUITING

    Marseille, 13385, France

  • Hôpital Louis Pasteur

    NOT_YET_RECRUITING

    Chartres, 28018, France

  • Hôpital Louis Pradel

    RECRUITING

    Bron, 69500, France

  • Hôpital Saint Louis

    NOT_YET_RECRUITING

    Paris, 75475, France

  • Hôpital de la Conception

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • Hôpital de la Conception

    NOT_YET_RECRUITING

    Marseille, 13005, France

  • Hôpital la Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpitaux de Brabois

    NOT_YET_RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

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