Informations générales (source: ClinicalTrials.gov)
Evaluation of Glucocorticoids Plus Rituximab Compared to Glucocorticoids Plus Placebo for the Treatment of Patients with Newly-Diagnosed or Relapsing IgA Vasculitis: a Prospective, Randomized, Controlled, Double-blind Study (RIGA)
Interventional
Phase 3
Hopital Foch (Voir sur ClinicalTrials)
mars 2022
janvier 2026
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| HOPITAL FOCH | jeudi 19 juin 2025 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM de La Timone - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHRU Bretonneau - 37044 - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont Ferrand - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU Clermont Ferrand - 63003 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU Marseille - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes (Caremeau) - 30029 - Nîmes - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| CHU Toulouse - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital André Grégoire - 93100 - Montreuil - France | Contact (sur clinicalTrials) | ||||
| Hôpital Edouard Herriot - 69003 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital La Cavale Blanche - 29200 - Brest - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.