Small study tests rituximab against rare vessel disease
NCT ID NCT03920722
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug rituximab, given with steroids, works better than steroids alone for people with a rare disease called microscopic polyangiitis that inflames small blood vessels. Only 8 patients took part, and the goal was to see if the combination could prevent relapses. Because the study is so small, the results are not conclusive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab
- What this could lead to
- If successful, this could point toward a more effective treatment for microscopic polyangiitis, reducing relapses.
- What could go wrong
- This is a very small, completed phase 3 trial with only 8 participants, so results may not apply broadly. Rituximab can cause infusion reactions and increase infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
8 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Sep 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient (male or female) over 18 year old 2. Patient agree to participate in the study and signed written informed consent 3. Patient with MPA according to the CHCC established in 2012 4. Absence of any poor prognosis factor (modified five factor score (FFS) 1996 = 0) 5. 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. 6. Patient with anti-MPO antibody measured by enzyme - linked immunosorbent assay (ELISA). 7. 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 Exclusion Criteria: 1. Small-sized vessels vasculitis not associated to anti-MPO antibody or associated with anti-PR3 positivity. 2. Patients with either GPA or EGPA vasculitis according to ACR criteria 3. Patient with a modified FFS 1996 ≥ 1 4. Patient with alveolar hemorrhage requiring mechanical ventilation 5. Patient with previous glucocorticoids treatment \>1 month and \> 10mg/day either for vasculitis or for any other reason. 6. Patient already receiving immunosuppressant or biological agent. 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. 7. Patient with a previous diagnosis of cancer \< 5 years (except for in situ cervical cancer and skin carcinoma with R0 resection) 8. Patient with acute infections or chronic active infections (HIV, hepatitis B or C) 9. Breast feeding woman or woman refusing the use of a contraceptive method for the 18 months' duration of the study 10. Contraindication to treatment (glucocorticoids or rituximab) 11. Unable to receive written informed consent of patient. Patient unable to understand the protocol 12. Patient already in another therapeutic protocol 13. Patient without social security 14. Patient with severe cardiac failure defined as class IV in New York Heart Association classification or severe, uncontrolled cardiac disease. 15. Patients with hypersensitivity to a monoclonal antibody or biological agent. 16. Patients in a severely immunocompromised state.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cochin Hospital
Paris, 75014, France
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Other studies related to the condition(s) this trial covers.
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