Evaluation of Glucocorticoids Plus Rituximab in Patients with Newly-Diagnosed or Relapsing IgA Vasculitis
RIGA
1 other identifier
interventional
75
1 country
14
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2022
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2021
CompletedStudy Start
First participant enrolled
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2026
CompletedMarch 13, 2025
March 1, 2025
3.4 years
August 9, 2021
March 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Rituximab efficacy
The proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at 180 days
180 days
Rituximab efficacy
The proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at 360 days
360 days
Secondary Outcomes (14)
Efficacy of rituximab-based regimen to induce remission
180 days
Efficacy of rituximab-based regimen to induce remission
360 days
Assessement the duration of remission
360 days
Assessment of patients achieving a complete or partial renal remission & renal outcome remission
180 days
Assessment of patients achieving a complete or partial renal remission & renal outcome remission
360 days
- +9 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALExperimental therapeutic strategy based on the use of rituximab in combination with glucocorticoids
control group
PLACEBO COMPARATORControl therapeutic strategy based on glucocorticoids plus placebo
Interventions
anti-CD20 monoclonal antibody leading to B-cell depletion, in relapsing and/or refractory IgAV patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
- Ministry of Health, Francecollaborator
Study Sites (14)
Hopital La Cavale Blanche
Brest, 29200, France
CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
CHU Clermont Ferrand
Clermont-Ferrand, 63003, France
Hôpital Edouard Herriot
Lyon, 69003, France
CHU Marseille
Marseille, 13005, France
APHM de La Timone
Marseille, 13385, France
Hôpital André Grégoire
Montreuil, 93100, France
CHU Nantes
Nantes, 44093, France
CHU Nîmes (Caremeau)
Nîmes, 30029, France
Hôpital Cochin
Paris, 75679, France
CHU Strasbourg
Strasbourg, 67091, France
Hôpital Foch
Suresnes, 92150, France
CHU Toulouse
Toulouse, 31059, France
CHRU Bretonneau
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romain Paule, Dr
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This trial will be comparative, randomized, double-blind and double-dummy in order to limit performance and evaluation bias. Neither patients, nor physicians will know the treatments allocated to their patients. Investigators will be in blind of the leukocyte formula during all study period, from day 1. Neither patients, nor physicians will know the treatments allocated to their patients. Investigators will be in blind of the CD19+ count during all study period, from day 15.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2021
First Posted
April 14, 2022
Study Start
March 11, 2022
Primary Completion
July 16, 2025
Study Completion
January 16, 2026
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share