Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
NCT ID: NCT03290456
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
146 participants
INTERVENTIONAL
2019-08-20
2029-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Low-dose Glucocorticoid Vasculitis Induction Study
NCT02198248
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
NCT02169219
Efficacy Study of Two Treatments in the Remission of Vasculitis
NCT00748644
Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
NCT00104299
Rituximab Plus Corticosteroids in Non-infectious Active Mixed Cryoglobulinemia Vasculitis
NCT02556866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prednisone 5mg/day extended of 12 additional months
Prednisone 5mg/day will be administered from Day 1 to Month 12
Prednisone 5mg/day extended of 12 additional months
Prednisone 5mg/day orally during 12 Month + 1 mg/week tapering until 0mg.
Placebo 5mg/day extended of 12 additional months
Placebo 5mg/day will be administered from Day 1 to Month 12
Placebo 5mg/day extended of 12 additionnal months.
1mg/week orally tapering Prednisone until Month 1 + Placebo orally 5mg/day until Month 13
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prednisone 5mg/day extended of 12 additional months
Prednisone 5mg/day orally during 12 Month + 1 mg/week tapering until 0mg.
Placebo 5mg/day extended of 12 additionnal months.
1mg/week orally tapering Prednisone until Month 1 + Placebo orally 5mg/day until Month 13
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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,
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Christophe LEGA, Pr
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens-Hôpital Nord
Amiens, , France
CHU Angers
Angers, , France
Clinique Rhône-Durance
Avignon, , France
Hôpital Jeanne d'Arc
Bar-le-Duc, , France
Hôpital Avicenne
Bobigny, , France
Hôpital La Cavale Blanche
Brest, , France
Hôpital Louis Pradel
Bron, , France
CHU de Caen - Cote de Nacre
Caen, , France
Hôpital Louis Pasteur
Chartres, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Gabriel Montpied
Clermont-Ferrand, , France
CHIC Créteil
Créteil, , France
CHRU François Mitterrand
Dijon, , France
CHRU François Mitterrand
Dijon, , France
CHRU Lille - Hôpital Claude Huriez
Lille, , France
Centre Hospitalier Croix Rousse
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital de la Conception
Marseille, , France
Hôpital de la Conception
Marseille, , France
Hôpital La Timone
Marseille, , France
HP Site Belle Isle
Metz, , France
CHU Nantes - Hôtel Dieu
Nantes, , France
CHU de Nice - Hôpital Pasteur 2
Nice, , France
Hôpital la Pitié Salpêtrière
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Européen G. Pompidou
Paris, , France
Hôpital Saint Louis
Paris, , France
Hôpital Haut Lévêque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CH Lyon Sud
Pierre-Bénite, , France
CH Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
CHRU Rennes - Hôpital Sud
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
CHU Strasbourg
Strasbourg, , France
CHRU Hautepierre
Strasbourg, , France
Hopitaux Universaitaire de Strasbourg Hopitaux
Strasbourg, , France
Hôpital Foch
Suresnes, , France
CHRU Bretonneau
Tours, , France
CH de Troyes
Troyes, , France
CH Valenciennes
Valenciennes, , France
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
CH de Verdun
Verdun, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL17_0020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.