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AzTrials

Granulomatosis With PolyangitisMAINEPSANNCT03290456

Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.

A study testing Prednisone 5mg/day extended of 12 additional months in people with Granulomatosis With Polyangitis, run by Hospices Civils de Lyon at 45 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Granulomatosis With Polyangitis
What is being tested?
Prednisone 5mg/day extended of 12 additional months
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
45 sitesFrance
Study dates
20 Aug 2019to 20 Oct 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 13Show fewer
  • 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,

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jean-Christophe LEGA, Pr contact

04.78.86.19.79

jean-christophe.lega@chu-lyon.fr

Xavier Puéchal, Dr contact

01.58.41.32.41

xavier.puechal@aphp.fr

45 sites in 1 country

France45 sites, 45 recruiting

  • CHU Amiens-Hôpital Nord

    Amiens, 80054

    Jean SCHMIDT, MD, 3 22 66 82 30 ext. +33, jean.schmidt@chu-amiens.fr

    Jean SCHMIDT, MD

    Recruiting

  • CHU Angers

    Angers, 49933

    Christian LAVIGNE, MD, 2 41 35 38 24 ext. +33, chlavigne@chu-angers.fr

    Christian LAVIGNE, MD

    Recruiting

  • Clinique Rhône-Durance

    Avignon, 84000

    Pierre GOBERT, MD, 4 32 75 30 59 ext. +33, pgobert@ch-avignon.fr

    Pierre GOBERT, MD

    Not yet recruiting

  • Hôpital Jeanne d'Arc

    Bar-le-Duc, 55000

    Philippe EVON, MD, 3.29.45.88.03 ext. +33, pevon@pssm.fr

    Philippe EVON, MD

    Not yet recruiting

  • Hôpital Avicenne

    Bobigny, 93009

    Robin DHOTE, MD, 1 48 95 58 70 ext. +33, robin.dhote@avc.aphp.fr

    Robin DHOTE, MD

    Not yet recruiting

  • Hôpital La Cavale Blanche

    Brest, 29200

    Claire DE MOREUIL, MD, 2.98.34.73.36 ext. +33, claire.demoreuil@chu-brest.fr

    Claire DE MOREUIL, MD

    Recruiting

  • Hôpital Louis Pradel

    Bron, 69500

    Vincent COTTIN, Pr, 4 72 35 70 72 ext. +33, vincent.cottin@chu-lyon.fr

    Vincent COTTIN, Pr

    Recruiting

  • CHU de Caen - Cote de Nacre

    Caen, 14033

    Nicolas MARTIN-SILVA, MD, 2 31 06 57 32 ext. +33, martinsilva.n@chu-caen.fr

    Nicolas MARTIN-SILVA, MD

    Recruiting

  • Hôpital Louis Pasteur

    Chartres, 28018

    Richard DAMADE, MD, 2 37 30 30 30 ext. +33, rdamade@ch-chartres.fr

    Richard DAMADE, MD

    Not yet recruiting

  • CHU Estaing

    Clermont-Ferrand, 63003

    Marc RUIVARD, Pr, 4 73 75 00 85 ext. +33, mruivard@chu-clermontferrand.fr

    Marc RUIVARD, Pr

    Recruiting

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003

    Olivier AUMAITRE, Pr, 4 73 75 14 35 ext. +33, oaumaitre@chu-clermontferrand.fr

    Olivier AUMAITRE, Pr

    Recruiting

  • CHIC Créteil

    Créteil, 94010

    Antoine FROISSART, MD, 1 45 17 54 80 ext. +33, antoine.froissart@chicreteil.fr

    Antoine FROISSART, MD

    Not yet recruiting

  • CHRU François Mitterrand

    Dijon, 21000

    Bernard BONNOTTE, Pr, 3 80 29 34 32 ext. +33, bernard.bonnotte@chu-dijon.fr

    Bernard BONNOTTE, Pr

    Not yet recruiting

  • CHRU François Mitterrand

    Dijon, 21000

    Jean-Michel REBIBOU, Pr, 3 80 29 34 34 ext. +33, Jean-michel.rebibou@chu-dijon.fr

    Jean-Michel REBIBOU, Pr

    Not yet recruiting

  • CHRU Lille - Hôpital Claude Huriez

    Lille, 59037

    Eric HACHULLA, Pr, 3 20 44 92 96 ext. +33, e-hachulla@chru-lille.fr

    Eric HACHULLA, Pr

    Not yet recruiting

  • Centre Hospitalier Croix Rousse

    Lyon, 69004

    Pascal SEVE, Pr, 4 26 73 26 36 ext. +33, pascal.seve@chu-lyon.fr

    Pascal SEVE, Pr

    Recruiting

  • Hôpital Edouard Herriot

    Lyon, 69137

    Arnaud HOT, Pr, 4 72 11 75 68 ext. +33, arnaud.hot@chu-lyon.fr

    Arnaud HOT, Pr

    Recruiting

  • Hôpital Edouard Herriot

    Lyon, 69137

    Laurent JULLIARD, Pr, 4 72 11 02 51 ext. +33, laurent.juillard@chu-lyon.fr

    Laurent JULLIARD, Pr

    Not yet recruiting

  • Hôpital de la Conception

    Marseille, 13005

    Gilles KAPLANSKI, Pr, 4 91 38 35 01 ext. +33, Gilles.kaplanski@ap-hm.fr

    Gilles KAPLANSKI, Pr

    Not yet recruiting

  • Hôpital de la Conception

    Marseille, 13005

    Noémie JOURDE CHICHE, Pr, 4 91 38 30 42 ext. +33, Noemie.jourde@ap-hm.fr

    Noémie JOURDE CHICHE, Pr

    Not yet recruiting

  • Hôpital La Timone

    Marseille, 13385

    Nicolas SCHLEINITZ, Pr, 4 91 38 87 62 ext. +33, nicolas.schleinitz@ap-hm.fr

    Nicolas SCHLEINITZ, Pr

    Not yet recruiting

  • HP Site Belle Isle

    Metz, 57045

    François MAURIER, MD, 3 57 84 15 01 ext. +33, francois.maurier@hp-metz.fr

    François MAURIER, MD

    Not yet recruiting

  • CHU Nantes - Hôtel Dieu

    Nantes, 44093

    Antoine NEEL, MD, 2 40 08 77 65 ext. +33, antoine.neel@chu-nantes.fr

    Antoine NEEL, MD

    Recruiting

  • CHU de Nice - Hôpital Pasteur 2

    Nice, 06001

    Nathalie TIEULIE, MD, 4 92 03 54 77 ext. +33, tieulie.n@chu-nice.fr

    Nathalie TIEULIE, MD

    Recruiting

  • Hôpital la Pitié Salpêtrière

    Paris, 75013

    Patrice CACOUB, Pr, 1 42 17 80 27 ext. +33, patrice.cacoub@psl.aphp.fr

    Patrice CACOUB, Pr

    Recruiting

  • Hôpital Cochin

    Paris, 75014

    Xavier PUECHAL, Pr, 1 58 41 29 71 ext. +33, xavier.puechal@aphp.fr

    Xavier PUECHAL, Pr

    Recruiting

  • Hôpital Européen G. Pompidou

    Paris, 75015

    Alexandre KARRAS, Pr, 1 56 09 37 60 ext. +33, alexandre.karras@egp.aphp.fr

    Alexandre KARRAS, Pr

    Not yet recruiting

  • Hôpital Saint Louis

    Paris, 75475

    Alfred MAHR, Pr, 1 42 49 97 80 ext. +33, alfred.mahr@sls.aphp.fr

    Alfred MAHR, Pr

    Not yet recruiting

  • Hôpital Haut Lévêque

    Pessac, 33600

    Jean-François VIALLARD, Pr, 5 57 65 64 83 ext. +33, jean-francois.viallard@chu-bordeaux.fr

    Jean-François VIALLARD, Pr

    Not yet recruiting

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310

    Jean-Christophe LEGA, Pr, 04.78.86.19.79, jean-christophe.lega@chu-lyon.fr

    Recruiting

  • CH Lyon Sud

    Pierre-Bénite, 69495

    Mathilde NOUVIER, Pr, 4 72 67 87 01 ext. +33, mathilde.nouvier@chu-lyon.fr

    Mathilde NOUVIER, Pr

    Recruiting

  • CH Lyon Sud

    Pierre-Bénite, 69495

    Jean Christophe LEGA, Pr, 4.78.86.19.79 ext. +33, jean-christophe.lega@chu-lyon.fr

    Jean Christophe LEGA, Pr

    Recruiting

  • CHU de Poitiers

    Poitiers, 86021

    Mathieu PUYADE, MD, 5 49 44 32 76 ext. +33, mathieu.puyade@chu-poitiers.fr

    Mathieu PUYADE, MD

    Not yet recruiting

  • CHRU Rennes - Hôpital Sud

    Rennes, 35200

    Thomas LE GALLOU, MD, 2 99 26 71 28 ext. +33, Thomas.LE.GALLOU@chu-rennes.fr

    Thomas LE GALLOU, MD

    Recruiting

  • Hôpital Charles Nicolle

    Rouen, 76031

    Ygal BENHAMOU, MD, 2 32 88 90 14 ext. +33, ygal.benhamou@chu-rouen.fr

    Ygal BENHAMOU, MD

    Recruiting

  • CHU Strasbourg

    Strasbourg, 67000

    Vincent POINDRON, MD, 3 69 55 05 21 ext. +33, vincent.poindron@chru-strasbourg.fr

    Vincent POINDRON, MD

    Not yet recruiting

  • CHRU Hautepierre

    Strasbourg, 67098

    Jacques-Eric GOTTENBERG, Pr, 3 88 12 79 54 ext. +33, jacques-eric.gottenberg@chru-strasbourg.fr

    Jacques-Eric GOTTENBERG, Pr

    Not yet recruiting

  • Hopitaux Universaitaire de Strasbourg Hopitaux

    Strasbourg

    Thierry KRUMMEL, MD, 3 69 55 13 22 ext. +33, Thierry.krummel@chru-strasbourg.fr

    Thierry KRUMMEL, MD

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Mathieu GROH, MD, 1 46 25 24 16 ext. +33, je.kahn@hopital-foch.org

    Mathieu GROH, MD

    Not yet recruiting

  • CHRU Bretonneau

    Tours, 37044

    Elisabeth DIOT, MD, 2 47 47 98 19 ext. +33, elisabeth.diot@chu-tours.fr

    Elisabeth DIOT, MD

    Not yet recruiting

  • CH de Troyes

    Troyes, 10003

    Pascale CHAUVEAU-JOUVE, MD, 3 25 49 49 49 ext. +33, pascale.chauveau-jouve@ch-troyes.fr

    Pascale CHAUVEAU-JOUVE, MD

    Recruiting

  • CH Valenciennes

    Valenciennes, 59322

    Thomas QUEMENEUR, MD, 3 27 14 30 89 ext. +33, quemeneur-t@ch-valenciennes.fr

    Thomas QUEMENEUR, MD

    Recruiting

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

    Rolland JAUSSAUD, MD, 3 83 15 40 60 ext. +33, r.jaussaud@chru-nancy.fr

    Rolland JAUSSAUD, MD

    Not yet recruiting

  • CH Bretagne Atlantique

    Vannes, 56017

    Pascal GODMER, MD, 2 97 01 41 45 ext. +33, pascal.godmer@ch-bretagne-atlantique.fr

    Pascal GODMER, MD

    Recruiting

  • CH de Verdun

    Verdun, 55100

    Assetou DIARRASOUBA, MD, 3 29 83 64 42 ext. +33, adiarrassouba@ch-verdun.fr

    Assetou DIARRASOUBA, MD

    Not yet recruiting

Other trials in France

About this study

Official title: A Prospective, Multicentric, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.

Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death.

Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile . Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated.

Read more

On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment.

In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months).

The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone.

The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.

Read the detailed description

Immunosuppressive therapy of granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis (MPA) has transformed the outcome from death to a strong likelihood of disease control and temporary remission. However, most patients have recurrent relapses that lead to damage and require repeated treatment associated with long-term morbidity and death.

Rituximab has been shown to be as effective as cyclophosphamide to induce remission and maintenance of remission in severe GPA and MPA patients, with an acceptable safety profile. Although rituximab is becoming the standard of care for maintenance therapy in these patients, relapse still occurs and the optimal duration of prednisone therapy remains debated.

On the one hand, most US studies use early withdrawal (6-12 months) because of feared side effects. On the other hand, most European trials propose late withdrawal (>18 months) given a lower observed relapse rate on long-term low dose glucocorticoids treatment.

In a systematic review and meta-analysis, glucocorticoids regimen was the most significant variable explaining the variability between the proportions of ANCA-associated vasculitis patients with relapses. Nevertheless, it was an indirect estimation of treatment effect because of the absence of dedicated randomized trial. This meta-analysis concluded that combined longer-term (i.e. >12 months) use of low dose prednisone or nonzero glucocorticoids target is associated with a 20% reduction of relapse compared to early withdrawal (i.e. ≤12 months).

The relapse rate in patients with early glucocorticoids (10-12 months) withdrawal was provided in two studies and was of 37 and 34%, respectively. By contrast, the relapse rate in patients with late prednisone withdrawal (18-24 months) and receiving rituximab as maintenance treatment was 14% at 24 months in the MAINRITSAN trial. Of note, the decision to withdraw glucocorticoids after 18 months was left to physician's discretion in this study and two thirds of the nonsevere relapses occurred when patients were off prednisone.

The trial detailed here is the first prospective trial evaluating the length of glucocorticoid administration as remission adjunctive treatment for patients with GPA or MPA.

Being tested
Prednisone 5mg/day extended of 12 additional months, Placebo 5mg/day extended of 12 additionnal months.
Keywords
Vasculitis, GPA, Granulomatosis with Polyangitis, MPA, Microscopic Polyangitis, Systemic anti-neutrophil cytoplasmic antibodies (ANCA), Prednisone, glucocorticoids, Remission Maintenance, Rituximab, Cyclophosphamide
Medical subject headings
Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prednisone 5mg/day extended of 12 additional monthsDrug

    Prednisone 5mg/day orally during 12 Month + 1 mg/week tapering until 0mg.

  • Placebo 5mg/day extended of 12 additionnal months.Drug

    1mg/week orally tapering Prednisone until Month 1 + Placebo orally 5mg/day until Month 13

Study groups in NCT03290456
Study groupRoleWhat they receive
Prednisone 5mg/day extended of 12 additional monthsExperimentalPrednisone 5mg/day will be administered from Day 1 to Month 12
Receives: Drug: Prednisone 5mg/day extended of 12 additional months
Placebo 5mg/day extended of 12 additional monthsPlacebo comparatorPlacebo 5mg/day will be administered from Day 1 to Month 12
Receives: Drug: Placebo 5mg/day extended of 12 additionnal months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relapse-free survival, relapse being defined as BVAS > 0.

    rate of relapse-free survival of patients continuing low-dose prednisone treatment until Month 10 VS those who will have prednisone treatment cessation at Month 1, on remission maintenance with Rituximab therapy, after achievement of remission of GPA or MPA, defined as a survival of patients maintaining a BVAS=0 at Month 30, in patient with newly-diagnosed or relapsing GPA or MPA and who will all have received glucocorticoids for 12 months after diagnosis or last flare before inclusion.

    Measured: from Screening to Month 30.

Secondary outcomes (11)

  1. Compare the rate of serious adverse events between Inclusion and Month 30 after randomization

    Proportion of patients with at least one adverse event between inclusion and Month 30.

    • Percentage of patients with at least one serious adverse event between inclusion and Month 30, corresponding to any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or congenital anomaly/birth defect or any other adverse event considered "medically significant".
    • Number of deaths, whatever the cause at Month 30.

    Measured: from Day 1 to Month 30

  2. Compare the rate of predefined severe events related to glucocorticoids between inclusion and Month 30 including osteoporotic fracture and weight gain.

    Percentage of patients with at least one predefined severe event corresponding to adverse events of grade 3 to 5 of the Common Terminology Criteria, including severe side effect related to glucocorticoids (infection requiring hospitalization or intravenous antibiotics, osteoporotic fracture, diabetes requiring medication, cardiovascular event, symptomatic osteonecrosis, psychiatric or mood disorder requiring drug administration, weight gain >10 kg) between inclusion and Month 30

    • Weight gain between inclusion and Month 30

    Measured: From Screening to Month 30

  3. To compare the rate of vasculitis relapse at Month 30

    Proportion of patients with minor or major vasculitis relapse between inclusion and Month 30 (BVAS >0) and time to first vasculitis relapse

    Measured: from Day 1 to Month 30

  4. To compare the prednisone use between inclusion and Month 30

    Prednisone area under the curve of administrated dose between inclusion and Month 30

    Measured: from screening to Month 30

  5. To compare variation of the Bone mineral density and markers between inclusion and Month 30

    Variation of the Bone mineral density between inclusion and Month 30

    • Variation of the Bone markers including C-terminal crosslinked telopeptide of type I collagen (CTX) and serum procollagen type 1 amino-terminal propeptide (P1NP) between inclusion and Month 30

    Measured: From Screening to Month 30

  6. To compare sequelae assessed by BVAS (vasculitis activity) at 30 months

    BVAS (vasculitis activity) at 30 months

    • Variation of BVAS (Vasculitis activity)

    Measured: From Screening to Month 30.

  7. To compare sequelae assessed by the Vasculitis Damage Index (VDI) at 30 months

    • Vasculitis Damage Index at 30 months
    • Variation of VDI,

    Measured: From screening to Month 30.

  8. - To compare sequelae assessed by Combined Damage Assessment Index (CDA) at 30 months

    • Combined Damage Assessment Index at 30 months
    • Variation of CDA (damage),

    Measured: From Screening to Month 30.

  9. - To compare functional disability at Month 30 after randomization (Day 1) in both arms

    Variation of HAQ (disability) between inclusion and at Month 30

    Measured: From Day 1 to Month 30.

  10. To compare quality of life at Month 30 after randomization (Day 1) in both arms

    • Variation of SF-36 (quality of life) between inclusion and at Month 30

    Measured: - From Day 1 to Month 30.

  11. - To compare healthcare resource utilization at Month 30 after randomization (Day 1) in both arms

    • Healthcare resource utilization between inclusion and Month 30 being defined as the percentage of patients being hospitalized at least once except only for rituximab infusions

    Measured: From Day 1 to Month 30.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start20 Aug 2019
  3. Primary completion20 Oct 2029 (estimated)
  4. Study completion20 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03290456
Sponsor's protocol ID
69HCL17_0020
Acronym
MAINEPSAN
Status last verified
Sep 2025
First submitted
24 Aug 2017
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prednisone 5mg/day extended of 12 additional months in people with Granulomatosis With Polyangitis, run by Hospices Civils de Lyon at 45 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Christophe LEGA, Pr (04.78.86.19.79, jean-christophe.lega@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse-free survival, relapse being defined as BVAS > 0. (time frame: from Screening to Month 30.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03290456.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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