Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients With Newly-Diagnosed or Relapsing IgA Vasculitis (RIGA)

  • STATUS
    Recruiting
  • End date
    Mar 11, 2026
  • participants needed
    72
  • sponsor
    Hopital Foch
Updated on 29 April 2022

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.

Details
Condition IgA Vasculitis
Treatment Placebo, RiTUXimab Injection
Clinical Study IdentifierNCT05329090
SponsorHopital Foch
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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 12 months
Patients treated with immunosuppressive therapy within the last 3 months
Patients with hypersensitivity to human or chimeric monoclonal antibodies
Patients with contraindication to use rituximab
Patients treated with any concomitant drugs contraindicated for use with the rituximab according to its SmPC
Patients with contraindication to use routine care treatments (Glucocorticoids, Angiotensin-converting-enzyme (ACEis) or angiotensin receptor blockers (ARBs), dexchlorphéniramine)
Patients in a severely immunocompromised state
Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric disorders, that could interfere with his/her compliance to protocol requirements
Patients currently participating in another clinical study or 3 months prior to randomization
Patients suspected not to be observant to the proposed treatments
Patients unable to give written informed consent prior to participation in the study
Being deprived of liberty or under guardianship
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