Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis

Phase 1

• Conditions: Patients with newly diagnosed or relapsing MPA, without any poor prognosis marker (FFS=0). Stratification will be made according to peripheral nerve involvement.; MedDRA version: 20.0 Level: PT Classification code 10063344 Term: Microscopic polyangiitis System Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-000637-12-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-31
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 106

Inclusion Criteria

1. Patient (male or female) aged 18 years old and over
2. Patient agreement 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=3, who did not receive any other treatment than glucocorticoids over the last month. One to 3 initial glucocorticoids pulse(s) are allowed.
6. Patient with anti-MPO antibody measured by ELISA
7. Negative pregnancy test (serum ß-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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1. Small-sized vessels vasculitis not associated with 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 haemorrhage 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 (including 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 according to New York Heart Association classification.
15. Patients with hypersensitivity to a monoclonal antibody or biological agent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified