Status:
RECRUITING
Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Granulomatosis With Polyangitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2029
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT03290456
Start Date
August 20 2019
End Date
October 20 2029
Last Update
September 15 2025
Active Locations (45)
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1
CHU Amiens-Hôpital Nord
Amiens, France, 80054
2
CHU Angers
Angers, France, 49933
3
Clinique Rhône-Durance
Avignon, France, 84000
4
Hôpital Jeanne d'Arc
Bar-le-Duc, France, 55000