🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
NCT03290456 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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 mo

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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,
💊

What it tests

  • Prednisone 5mg/day extended of 12 additional months
  • Placebo 5mg/day extended of 12 additionnal months.
📍

Where

45 sites
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

…and 37 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy