Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Va… (NCT05329090) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Vasculitis
France75 participantsStarted 2022-03-11
Plain-language summary
Systemic vasculitis are inflammatory diseases of the blood vessels, responsible for systemic manifestations. Among the systemic vasculitis affecting small blood vessels, IgA vasculitis (IgAV) is one of the most common forms and mainly affects the skin, joints, kidneys and gastrointestinal tract. Kidney and gastrointestinal damage can be serious, causing complications and life-threatening sequelae, especially in adults. The treatment of adult-onset IgAV is still a matter of debate. Glucocorticoids have been the standard of care for inducing remission for years in severe forms of IgAV. However, not all patients achieve remission and may experience disease flares associated with increased morbidity and mortality. In addition, the cumulative side effects of glucocorticoids are also major causes of long-term adverse events and death.Rituximab (RTX), an anti-CD20 monoclonal antibody, has been shown to be spectacularly effective in inducing remission in d 'other small vascular vessels, in particular ANCA-associated vasculitis and cryoglobulinemic vasculitis, with an acceptable safety profile.
Recently, a multicenter observational study suggested that RTX was an effective and safe therapeutic option for treating relapsed and / or refractory adult IgAV.
Overall, RTX may be an effective and safe therapeutic approach in adult IgAVs, justifying the need for a prospective randomized controlled trial evaluating Rituximab as an induction of remission for adult IgAV.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Biopsy-proven diagnosis of IgAV according to Chapel Hill Consensus Conference definitions
* Patient aged of 18 years or older
* Patients with newly-diagnosed disease or relapsing disease at the time of screening, with an active disease defined by active manifestations attributable to IgAV
* Patients with severe involvement of at least one organ
* Patients within the first 21 days following initiation/increase of glucocorticoids at a dose \< 1 mg/kg/day
* Has signed an informed consent form prior to any study related procedures
* Affiliated to a national health insurance
Exclusion Criteria:
* Patients with ANCA-associated vasculitis, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
* Patients with IgAV in remission of the disease,
* Patients with severe cardiac failure defined as class IV in New York Heart Association,
* Patients with severe, uncontrolled cardiac disease,
* Patients with acute infections or chronic active infections (including HIV, HBV or HCV),
* Patients with active cancer or recent malignancy (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
* Pregnant women and breastfeeding. Patients with childbearing potential must use reliable contraceptive methods throughout the study and at least for 12 months after the last study drug administration,
* Patients with IgAV who have already been treated with rituximab within the previous 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 3 trial testing rituximab added to glucocorticoids for IgA vasculitis, can you explain what the results showed and whether that combination is now considered a strong treatment option for my specific situation — newly diagnosed or relapsing?
2Rituximab works by depleting B cells and suppressing the immune system — given my overall health and any infections I've had, are there particular safety risks I should know about before considering this kind of treatment?
3This trial has already completed recruitment, so the data may be available or coming soon — do you have access to the findings, and how might they change the treatment plan you'd recommend for me?
4How does adding rituximab to glucocorticoids compare to standard glucocorticoid treatment alone for IgA vasculitis, and is there a reason you might recommend one approach over the other for my case?
5Since this trial enrolled both newly diagnosed and relapsing patients, does it matter which category I fall into when thinking about whether rituximab would be worth discussing as part of my treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.