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New treatment option for Granulomatosis With Polyangitis
Official title Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis.
ClinicalTrials.gov ID: NCT03290456
What this study is testing
What is Prednisone 5mg/day extended of 12 additional months?
Prednisone 5mg/day extended of 12 additional months is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for granulomatosis with polyangitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- 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...
- 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...
See the full eligibility 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
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Avignon, France
- Bar-le-Duc, France
- Bobigny, France
- Brest, France
- Bron, France
- Caen, France
- Chartres, France
- Clermont-Ferrand, France
- Créteil, France
- Dijon, France
- Lille, France
- Lyon, France
- Marseille, France
- Metz, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
+ 12 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Avignon, France; Bar-le-Duc, France; Bobigny, France; Brest, France and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.