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Microscopic Polyangiitis (MPA)Phase 3RITUXGOPRONCT03920722

Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis

A Phase 3 study testing Rituximab in people with Microscopic Polyangiitis (MPA), run by Assistance Publique - Hôpitaux de Paris at 1 site 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

The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Microscopic Polyangiitis (MPA)
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
1 siteFrance
Study dates
24 Oct 2020to 6 Sep 2023
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

  • Patient (male or female) over 18 year old
  • Patient agree to participate in the study and signed written informed consent
  • Patient with MPA according to the CHCC established in 2012
  • Absence of any poor prognosis factor (modified five factor score (FFS) 1996 = 0)
  • Patient with recent onset or relapse of the disease (<1 month) defined by BVAS > 0, who did not received any other treatment than glucocorticoids during last month. For patients with a BVAS<3, activity of vasculitis (either relapse or new onset) has to be confirmed by the coordinating investigator. One to 3 initial glucocorticoids pulse(s) are allowed.
  • Patient with anti-MPO antibody measured by enzyme - linked immunosorbent assay (ELISA).
  • Negative pregnancy test (serum β-hCG) for women of child-bearing potential and a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 12 months after stopping therapy

Who cannot join

  • Small-sized vessels vasculitis not associated to anti-MPO antibody or associated with anti-PR3 positivity.
  • Patients with either GPA or EGPA vasculitis according to ACR criteria
  • Patient with a modified FFS 1996 ≥ 1
  • Patient with alveolar hemorrhage requiring mechanical ventilation
  • Patient with previous glucocorticoids treatment >1 month and > 10mg/day either for vasculitis or for any other reason.
  • Patient already receiving immunosuppressant or biological agent.
Show all 21Show fewer
  • Prior treatment with any of the following:
  • azathioprine, methotrexate, mycophenolate mophetil, mycophenolic acid within 4 weeks before inclusion
  • alkylant agent such as cyclophosphamide within 6 months before inclusion
  • anti-TNF inhibitors : infliximab within 8 weeks, adalimumab and etanercept within 2 weeks before inclusion
  • anti-CD20 therapy within one year before inclusion.
  • Patient with a previous diagnosis of cancer < 5 years (except for in situ cervical cancer and skin carcinoma with R0 resection)
  • Patient with acute infections or chronic active infections (HIV, hepatitis B or C)
  • Breast feeding woman or woman refusing the use of a contraceptive method for the 18 months' duration of the study
  • Contraindication to treatment (glucocorticoids or rituximab)
  • Unable to receive written informed consent of patient. Patient unable to understand the protocol
  • Patient already in another therapeutic protocol
  • Patient without social security
  • Patient with severe cardiac failure defined as class IV in New York Heart Association classification or severe, uncontrolled cardiac disease.
  • Patients with hypersensitivity to a monoclonal antibody or biological agent.
  • Patients in a severely immunocompromised state.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Cochin Hospital

    Paris, 75014

Other trials in France

About this study

The purpose of the study is to determine wether a rituximab-based treatment compared to standard therapy (glucocorticoid alone) in patients with microscopic polyangiitis without any bad prognosis marker increases the remission and reduces the relapse free survival rate.

Read the detailed description

Microscopic polyangiitis (MPA), is a small-sized vessel necrotizing vasculitis associated with anti-neutrophils cytoplasmic antibody (ANCA). Treatment of ANCA associated vasculitis (AAV) was previously based on glucocorticoids (GC) and cyclophosphamide. It has been demonstrated in two prospective randomized trials that rituximab is as effective as cyclophosphamide in the induction treatment of GPA and severe MPA. In addition, it was shown in GPA and MPA that rituximab is superior to azathioprine as maintenance therapy.

Patients with MPA without poor prognosis factor (Five factor score (FFS)=0) have not been included in the previous studies and GC alone is considered as the reference treatment in these patients. However, as much as 50% of these patients experience relapses after a 24 months follow-up and only 40% of patients have a long lasting remission.

In the group of patients with MPA without any poor prognosis factor (FFS=0), an additional treatment with rituximab might decrease the relapse rate from 40% to 15% after an 18 months' follow-up. The efficacy and safety of this proposal must be tested.

Being tested
Rituximab, placebo
Keywords
MPA, Rituximab, ANCA-associated vasculitis
Medical subject headings
Microscopic Polyangiitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

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

  • RituximabDrug

    1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine

  • placeboDrug

    Placebo-Rituximab 1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine

Study groups in NCT03920722
Study groupRoleWhat they receive
RituximabExperimentalExperimental regimen: One year Glucocorticoid treatment and Rituximab IV 1 gram on Day 1 and 15
Receives: Drug: Rituximab
Rituximab-PlaceboPlacebo comparatorStandard regimen: One-year Glucocorticoid treatment and Placebo-Rituximab IV on Day 1 and 15
Receives: Drug: placebo

What is being measured

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

  1. Disease free survival rate

    Failure free survival in patients with microscopic polyangiitis treated with rituximab and glucocorticoids compared to glucocorticoids alone.

    • Primary failure: Vasculitis requiring a modification of immunosuppressive treatment or prednisone tapering protocol before M3
    • Remission is defined by the absence of sign attributable to vasculitis and a Birmingham Vasculitis Activity Score (BVAS)=0 at M3
    • Relapse is defined after visit M3 by a BVAS>0 or the impossibility to decrease glucocorticoids according to the predefined protocol. Therefore, patients who experience a primary failure or fail to enter remission or relapse will be considered as treatment failure. Death will also be considered as a treatment failure

    Measured: 18 months

Secondary outcomes (12)
  1. Cumulative dose of GC in each group

    GC dose will be recorded at each visit

    Measured: 18 months

  2. Proportion of patients who achieve a complete remission defined by the absence of sign attributable to vasculitis and a BVAS=0

    Absence of sign attributable to vasculitis and a BVAS=0 at M3

    Measured: 1 month

  3. Compare proportion of patients who relapse and time to first relapse

    Relapse is defined after visit M3 by the reoccurrence of signs or symptoms attributable to vasculitis and a BVAS≥1 or the impossibility to decrease GC therapy according to the predefined protocol

    Measured: 18 months

  4. Among patients who relapse, proportion of major relapses

    Major relapse is defined by reappearance or worsening of disease with a BVAS≥1 and involvement of at least one major organ, a life-threatening manifestation, or both

    Measured: 18 months

  5. Among patients who relapse, proportion of minor relapses

    Minor relapse is defined by reappearance or worsening of disease with a BVAS≥1, not corresponding to a major relapse

    Measured: 18 months

  6. Mortality rate

    Proportion will be compared between groups

    Measured: 18 months

  7. Quality of life:Short Form Health Survey Questionnaire (SF-36)

    Assessed by mean variation of the SF-36 The 36-Item Short Form Health Survey questionnaire (SF-36) questionnaire includes 36 items related to eight health component (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.) A scale has been established for each component and results vary from 0 (bad health perception) to 100 (good health perception).

    Measured: 18 months

  8. Disability

    Assessed by the mean variation of the Health Assessment Questionnaire (HAQ) Health Assessment Questionnaire (HAQ) is a questionnaire that evaluates the disability of the patient. Results vary from 0 (no assistance is needed) to 3 (patient usually needs both a special device and help from another person).

    Measured: 18 months

  9. Disability

    Assessed by the mean variation of the Euroqol 5D (EQ-5D). The EuroQol-5 dimension (EQ-5D-3L) is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D is made up of five dimensions (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each of which can be rated at one of three levels (no problem, some problems, extreme/severe problems). The EuroQol questionnaire also contains a visual analogue scale (EQ-VAS), where patients are asked to rate their current health state on a 0 (worst imaginable health state) to 100 (best imaginable health state) scale.

    Measured: 18 months

  10. Severity of sequels linked to vasculitis as

    Assessed by comparison of the VDI score. The Vascular Damage index score documents any organ damage that has occurred in patients since the onset of vasculitis. The score includes 64 items that are categorized into 11 groups (by organ system) and result is the summ of each damaged items.

    Measured: 18 months

  11. Proportion of patients who still receive GC at the end of follow-up

    Proportion will be compared between groups

    Measured: 18 months

  12. Number and severity of side effect.

    Record of adverse events and serious adverse events related to vasculitis or treatment in each group. Classification is made according to the CTCAE toxicity grading system.

    Measured: 18 months

Timeline

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

  1. First posted19 Apr 2019
  2. Study start24 Oct 2020
  3. Primary completion6 Sep 2023
  4. Study completion6 Sep 2023

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03920722
Sponsor's protocol ID
P170909J
Other IDs
2018-000637-12, 2018
Acronym
RITUXGOPRO
Status last verified
Apr 2026
First submitted
18 Feb 2019
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guillevin L, Pagnoux C, Karras A, Khouatra C, Aumaitre O, Cohen P, Maurier F, Decaux O, Ninet J, Gobert P, Quemeneur T, Blanchard-Delaunay C, Godmer P, Puechal X, Carron PL, Hatron PY, Limal N, Hamidou M, Ducret M, Daugas E, Papo T, Bonnotte B, Mahr A, Ravaud P, Mouthon L; French Vasculitis Study Group. Rituximab versus azathioprine for maintenance in ANCA-associated vasculitis. N Engl J Med. 2014 Nov 6;371(19):1771-80. doi: 10.1056/NEJMoa1404231.

    PubMed 25372085
  • Specks U, Merkel PA, Seo P, Spiera R, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Fessler BJ, Ding L, Viviano L, Tchao NK, Phippard DJ, Asare AL, Lim N, Ikle D, Jepson B, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh K, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Mueller M, Sejismundo LP, Mieras K, Stone JH; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis. N Engl J Med. 2013 Aug 1;369(5):417-27. doi: 10.1056/NEJMoa1213277.

    PubMed 23902481
  • Stone JH, Merkel PA, Spiera R, Seo P, Langford CA, Hoffman GS, Kallenberg CG, St Clair EW, Turkiewicz A, Tchao NK, Webber L, Ding L, Sejismundo LP, Mieras K, Weitzenkamp D, Ikle D, Seyfert-Margolis V, Mueller M, Brunetta P, Allen NB, Fervenza FC, Geetha D, Keogh KA, Kissin EY, Monach PA, Peikert T, Stegeman C, Ytterberg SR, Specks U; RAVE-ITN Research Group. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010 Jul 15;363(3):221-32. doi: 10.1056/NEJMoa0909905.

    PubMed 20647199
  • Jones RB, Tervaert JW, Hauser T, Luqmani R, Morgan MD, Peh CA, Savage CO, Segelmark M, Tesar V, van Paassen P, Walsh D, Walsh M, Westman K, Jayne DR; European Vasculitis Study Group. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis. N Engl J Med. 2010 Jul 15;363(3):211-20. doi: 10.1056/NEJMoa0909169.

    PubMed 20647198
  • Samson M, Puechal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Ruivard M, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Long-term follow-up of a randomized trial on 118 patients with polyarteritis nodosa or microscopic polyangiitis without poor-prognosis factors. Autoimmun Rev. 2014 Feb;13(2):197-205. doi: 10.1016/j.autrev.2013.10.001. Epub 2013 Oct 23.

    PubMed 24161361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Microscopic Polyangiitis (MPA), run by Assistance Publique - Hôpitaux de Paris at 1 site 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 21 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Disease free survival rate (time frame: 18 months). 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 NCT03920722, which also lists 5 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 6 May 2026.

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