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Extended low-dose prednisone to maintain remission in ANCA-associated vasculitis

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.

NA · Hospices Civils de Lyon · NCT03290456

This trial tests whether continuing a low 5 mg daily dose of prednisone for an additional 12 months helps adults with granulomatosis with polyangiitis or microscopic polyangiitis who are in remission after rituximab stay relapse-free.

Quick facts

PhaseNA
Study typeInterventional
Enrollment146 (estimated)
Ages18 Years and up
SexAll
SponsorHospices Civils de Lyon (other)
Drugs / interventionsrituximab, prednisone, cyclophosphamide
Locations45 sites (Amiens and 44 other locations)
Trial IDNCT03290456 on ClinicalTrials.gov

What this trial studies

Patients with GPA or MPA who are in remission on rituximab and taking low-dose prednisone are randomly assigned to continue 5 mg/day prednisone for 12 more months or to receive matching placebo. The trial compares relapse rates and safety between the extended-prednisone and placebo groups while all participants receive scheduled rituximab maintenance infusions. The design targets patients with inactive disease (BVAS = 0) and requires stable prednisone dosing at 5 mg/day at randomization. The study responds to conflicting practices about prednisone duration and to meta-analytic signals that longer low-dose glucocorticoids may reduce relapses.

Who should consider this trial

Good fit: Adults (≥18) with a diagnosis of GPA or MPA who are in remission (BVAS = 0), receiving rituximab maintenance and taking 5 mg/day prednisone at the time of randomization are ideal candidates.

Not a fit: Patients with active disease, EGPA or other non-GPA/MPA vasculitides, chronic active infections, or those not tolerating or unable to remain at 5 mg/day prednisone are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, continuing low-dose prednisone could lower relapse risk and reduce the need for repeated high-intensity immunosuppression and its associated complications.

How similar studies have performed: Rituximab is proven for induction and maintenance, and meta-analyses of observational data suggest >12 months of low-dose glucocorticoids cuts relapse risk by about 20%, but a dedicated randomized trial on prednisone duration has been lacking.

Eligibility criteria

Show full inclusion / exclusion criteria 
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,

Where this trial is running

Amiens and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Granulomatosis With Polyangitis, Vasculitis, GPA, Granulomatosis with Polyangitis, MPA, Microscopic Polyangitis, Systemic anti-neutrophil cytoplasmic antibodies, Prednisone

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.