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IgA VasculitisPhase 3RIGANCT05329090

Evaluation of Glucocorticoids Plus Rituximab in Patients With Newly-Diagnosed or Relapsing IgA Vasculitis

A Phase 3 study testing Rituximab Injection in people with IgA Vasculitis, run by Hopital Foch at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
IgA Vasculitis
What is being tested?
Rituximab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
14 sitesFrance
Study dates
11 Mar 2022to 13 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 19Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Hopital La Cavale Blanche

    Brest, 29200

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63003

  • Hôpital Edouard Herriot

    Lyon, 69003

  • CHU Marseille

    Marseille, 13005

  • APHM de La Timone

    Marseille, 13385

  • Hôpital André Grégoire

    Montreuil, 93100

  • CHU Nantes

    Nantes, 44093

  • CHU Nîmes (Caremeau)

    Nîmes, 30029

  • Hôpital Cochin

    Paris, 75679

  • CHU Strasbourg

    Strasbourg, 67091

  • Hôpital Foch

    Suresnes, 92150

  • CHU Toulouse

    Toulouse, 31059

  • CHRU Bretonneau

    Tours, 37044

Other trials in France

About this study

Official title: 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

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.

Conditions
IgA Vasculitis
Being tested
Rituximab Injection, placebo
Keywords
Rituximab
Medical subject headings
IgA Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab InjectionDrug

    Also called Rixathon, Truxima

    anti-CD20 monoclonal antibody leading to B-cell depletion, in relapsing and/or refractory IgAV patients

  • placeboDrug

    Also called NaCl

    placebo experimental treatment

Study groups in NCT05329090
Study groupRoleWhat they receive
experimental groupExperimentalExperimental therapeutic strategy based on the use of rituximab in combination with glucocorticoids
Receives: Drug: Rituximab Injection
control groupPlacebo comparatorControl therapeutic strategy based on glucocorticoids plus placebo
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rituximab efficacy

    The proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at 180 days

    Measured: 180 days

  2. Rituximab efficacy

    The proportion of patients alive who achieved remission with a prednisone dose of 0 mg/day at 360 days

    Measured: 360 days

Secondary outcomes (14)

  1. Efficacy of rituximab-based regimen to induce remission

    Proportion of patients with BVAS=0 (or BVAS of ≤5 if all scores were due to persistent hematuria or proteinuria) and a prednisone dose ≤5 mg/day at 180 days

    Measured: 180 days

  2. Efficacy of rituximab-based regimen to induce remission

    Proportion of patients with BVAS=0 (or BVAS of ≤5 if all scores were due to persistent hematuria or proteinuria) and a prednisone dose ≤5 mg/day at 360 days

    Measured: 360 days

  3. Assessement the duration of remission

    Proportion of patients achieving remission for ≥3 consecutive months over the 360 days, with BVAS=0 (or BVAS of ≤5 if all scores were due to persistent hematuria or proteinuria) and a prednisone dose ≤5 mg/day at 360 days.

    Measured: 360 days

  4. Assessment of patients achieving a complete or partial renal remission & renal outcome remission

    Proportion of patients in complete renal and partial renal remission at 180 days (Renal parameters at 180 days compared with baseline: eGFR, daily proteinuria, hematuria, arterial hypertension, use of angiotensin converting enzyme inhibitor, occurrence of end-stage renal disease)

    Measured: 180 days

  5. Assessment of patients achieving a complete or partial renal remission & renal outcome remission

    Proportion of patients in complete renal and partial renal remission at 360 days (Renal parameters at 360 days compared with baseline: eGFR, daily proteinuria, hematuria, arterial hypertension, use of angiotensin converting enzyme inhibitor, occurrence of end-stage renal disease)

    Measured: 360 days

  6. Measure of glucocorticoids dose

    Area under the curve for prednisone dose at 180 days in the two treatment groups

    Measured: 160 days

  7. Measure of glucocorticoids dose

    Area under the curve for prednisone dose at 360 days in the two treatment groups

    Measured: 360 days

  8. Number of participants with adverse events for the safety analyse

    Adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at days 180 and 360 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions, death

    Measured: 360 days

  9. The sequelae assessed by the Vasculitis Damage Index

    The Vasculitis Damage Index in the two treatment groups

    Measured: 180 days

  10. The sequelae assessed by the Vasculitis Damage Index

    The Vasculitis Damage Index in the two treatment groups

    Measured: 360 days

  11. Quality of life of patients

    HAQ and SF-36 questionnaires at 180 days

    Measured: 180 days

  12. Quality of life of patients

    HAQ and SF-36 questionnaires at 360 days

    Measured: 360 days

  13. Patient reported outcome

    The patient-reported outcomes (PRO) including patient-reported disease activity, anxiety and depression, burden of the disease and treatment and adherence to treatment, at days 180 and 360 after randomization in the two treatment groups, and during the long-term follow-up

    Measured: 360 days

  14. Patient survival

    Number of patient survival

    Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start11 Mar 2022
  3. Primary completion13 Jan 2026
  4. Study completion13 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Design of trial : * Controlled (the comparator is a Placebo) * Randomised * Double blind * Parallel groupe * With a double layering
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329090
Sponsor's protocol ID
2019_0068
Acronym
RIGA
Status last verified
Jun 2026
First submitted
9 Aug 2021
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gardner-Medwin JM, Dolezalova P, Cummins C, Southwood TR. Incidence of Henoch-Schonlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins. Lancet. 2002 Oct 19;360(9341):1197-202. doi: 10.1016/S0140-6736(02)11279-7.

    PubMed 12401245

  • Audemard-Verger A, Terrier B, Dechartres A, Chanal J, Amoura Z, Le Gouellec N, Cacoub P, Jourde-Chiche N, Urbanski G, Augusto JF, Moulis G, Raffray L, Deroux A, Hummel A, Lioger B, Catroux M, Faguer S, Goutte J, Martis N, Maurier F, Riviere E, Sanges S, Baldolli A, Costedoat-Chalumeau N, Roriz M, Puechal X, Andre M, Lavigne C, Bienvenu B, Mekinian A, Zagdoun E, Girard C, Berezne A, Guillevin L, Thervet E, Pillebout E; French Vasculitis Study Group. Characteristics and Management of IgA Vasculitis (Henoch-Schonlein) in Adults: Data From 260 Patients Included in a French Multicenter Retrospective Survey. Arthritis Rheumatol. 2017 Sep;69(9):1862-1870. doi: 10.1002/art.40178.

    PubMed 28605168

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab Injection in people with IgA Vasculitis, run by Hopital Foch at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rituximab efficacy (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05329090, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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