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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Amiens-Hôpital Nord
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• Hôpital La Cavale Blanche
  Brest, France Recruiting
• Hôpital Louis Pradel
  Bron, France Recruiting
• CHU de Caen - Cote de Nacre
  Caen, France Recruiting
• CHU Estaing
  Clermont-Ferrand, France Recruiting

Study contacts

• Principal investigator: Jean-Christophe LEGA, Pr — Hospices Civils de Lyon
• Study coordinator: Jean-Christophe LEGA, Pr
• Email: jean-christophe.lega@chu-lyon.fr
• Phone: 04.78.86.19.79

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.