Status:
ACTIVE_NOT_RECRUITING
Evaluation of Glucocorticoids Plus Rituximab in Patients with Newly-Diagnosed or Relapsing IgA Vasculitis
Lead Sponsor:
Hopital Foch
Collaborating Sponsors:
Ministry of Health, France
Conditions:
IgA Vasculitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05329090
Start Date
March 11 2022
End Date
January 16 2026
Last Update
March 13 2025
Active Locations (14)
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1
Hopital La Cavale Blanche
Brest, France, 29200
2
CHU Clermont Ferrand
Clermont-Ferrand, France, 63000
3
CHU Clermont Ferrand
Clermont-Ferrand, France, 63003
4
Hôpital Edouard Herriot
Lyon, France, 69003