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MAINEPSAN : A Prospective Comparative Randomized Double-blind Placebo-controlled In-Parallel Groups Multicenter, Study to Evaluate the remission MAINtenance using Extended administration of Prednisone in Systemic anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
EU CTIS ID: 2024-514156-33-00
What this study is testing
Relapse rate of patients continuing low-dose prednisone treatment until 13 months of treatment (Visit M13) versus those who will have prednisone treatment cessation after one month (visit M1), on remission maintenance with rituximab therapy, after achievement of remission of GPA or MPA, defined as patients maintaining a BVAS (Birmingham Vasculitis Activity Score)=0 at Month 30
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who has been informed about the study and has given his/her written informed consent prior to participation in the study
- Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status
- Patients aged of 18 years or older,
- Patients in remission (BVAS=0) for MPA or GPA achieved with rituximab, cyclophosphamide, or methotrexate,
- Patients who will all have already received glucocorticoids for 12 and 36 months ± 8 weeks after diagnosis or last flare before Day 1 for patients treated according the MAINRITSAN and MAINRITSAN3 protocols, respectively.
- 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
You likely can't join if
- Patients with GPA or MPA if glucocorticoids treatment has been increased > 10 mg/day for vasculitis flare or stopped during maintenance therapy
- Patients suspected not to be observant to the proposed treatments
- Patients who have neutrophils cell count ≤1.500 /mm3,
- Patients who have platelet count ≤100,000/mm3,
- Patients with severe hypogammaglobulinemia (invasive bacterial or fungal infection with IgG < 5 g/L or IgG < 3 g/L in patients without infection)
- Patients who have ALT or AST or GGT or PAL level greater than 3 times the upper limit of normal or total bilirubin level greater than 2 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease,
See the full eligibility criteria
- Patients who has been informed about the study and has given his/her written informed consent prior to participation in the study
- Patients with newly-diagnosed or relapsing MPA or GPA according to the ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definition, independently of ANCA status
- Patients aged of 18 years or older,
- Patients in remission (BVAS=0) for MPA or GPA achieved with rituximab, cyclophosphamide, or methotrexate,
- Patients who will all have already received glucocorticoids for 12 and 36 months ± 8 weeks after diagnosis or last flare before Day 1 for patients treated according the MAINRITSAN and MAINRITSAN3 protocols, respectively.
- 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
- Patients having received 500 mg low-dose rituximab maintenance infusion at remission achievement, according to the MAINRITSAN and MAINRITSAN3 trials
- Patients with GPA or MPA if glucocorticoids treatment has been increased > 10 mg/day for vasculitis flare or stopped during maintenance therapy
- Patients suspected not to be observant to the proposed treatments
- Patients who have neutrophils cell count ≤1.500 /mm3,
- Patients who have platelet count ≤100,000/mm3,
- Patients with severe hypogammaglobulinemia (invasive bacterial or fungal infection with IgG < 5 g/L or IgG < 3 g/L in patients without infection)
- Patients who have ALT or AST or GGT or PAL level greater than 3 times the upper limit of normal or total bilirubin level greater than 2 times the upper limit of normal that cannot be attributed to underlying MPA-GPA disease,
- Patients unable to give written informed consent prior to study participation.
- Patients under judicial protection,
- Patient not affiliated to a social security scheme or other social protection scheme,
- Patients who did not get vaccinated of covid-19 according to national recommendations.
- 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 including Sars COVID-19 or chronic active infections (including HIV, HBV or HCV)
- Patients with active cancer or recent cancer (<5 years) or myelodysplasia, except basocellular carcinoma and low activity prostatic cancer controlled by hormonal treatment
- Pregnant women and lactation. Patients with childbearing potential should have reliable contraception for the total duration of the study
- Patients with contraindication to use rituximab
- 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 excepted for the PNEUMOVAS trial.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.