Overview

Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis

Status:
Completed
Trial end date:
2016-04-05
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to assess the efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance treatment in systemic ANCA-associated vasculitis: prospective, multicenter, controlled, randomized comparative study of two rituximab regimens: one based on ANCA and CD19 lymphocytes versus systematic infusions.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Treatments:
Rituximab
Criteria
Inclusion Criteria:

- Granulomatosis with Polyangiitis Or microscopic polyangiitis complying Or
kidney-limited disease With or without detectable ANCA (anti-neutrophil cytoplasmic
antibodies) at the time of diagnosis or relapse, and at remission.

- Who have achieved remission using a treatment combining corticosteroids and an
immunosuppressive agent, including corticosteroids, cyclophosphamide IV or oral (the
use of another immunosuppressant is allowed, according to the current French
guidelines, as well as plasma exchanges and/or IV immunoglobulins, or rituximab).

- Interval of 1 month between the end of the immunosuppressant treatment and the
randomization time if cyclophosphamide or methotrexate were used, interval between 4
and 6 months if rituximab was used

- Age > 18 years without age limit higher when the diagnosis is confirmed.

- Informed and having signed the consent form to take part in the study.

Exclusion Criteria:

- Other systemic vasculitis

- Secondary vasculitis (following neoplastic disease or an infection in particular)

- Induction treatment with a regimen not corresponding to that recommended in France.

- Patient who has not achieved remission.

- Incapacity or refusal to understand or sign the informed consent form.

- Incapacity or refusal to adhere to treatment or perform the follow-up examinations
required by the study. Non-compliance

- Allergy, documented hypersensitivity or contraindication to the study medication
(cyclophosphamide, corticosteroids, azathioprine, rituximab)

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies.

- Pregnancy, breastfeeding. Women of childbearing age must use a reliable method of
contraception throughout the duration of immunosuppressive treatment up to 1 year
after the last infusion of rituximab

- Infection by HIV, HCV or HBV

- Progressive, uncontrolled infection requiring a prolonged treatment (tuberculosis, HIV
infection, etc.).

- Severe infection declared during the 3 months before randomization (CMV, HBV, HHV8,
HCV, HIV, tuberculosis).

- Progressive cancer or malignant blood disease diagnosed during the 5 years before the
diagnosis of vasculitis. Patients suffering from non-metastatic prostate cancer or
those cured of a cancer or a malignant blood disorder for more than 5 years and not
taking any antineoplastic agents for more than 5 years may be included.

- Participation in another clinical research protocol during the 4 weeks before
inclusion.

- Any medical or psychiatric disorder which, in the investigator's opinion, may prevent
the administration of treatment and patient follow-up according to the protocol,
and/or which may expose the patient to a too greater risk of an adverse effect.

- No social security

- Churg and Strauss syndrome

- Viral, bacterial or fungic or mycobacterial infection uncontrolled in the 4 weeks
before the inclusion

- History of deep tissue infection (fasciitis, osteomyelitis, septic arthritis)in the
first year before the inclusion

- History of chronic and severe or recurrent infection or history of preexisting disease
predisposing to severe infection

- Severe immunodepression

- Administration of live vaccine in the four weeks before inclusion

- Severe chronic obstructive pulmonary diseases (VEMS < 50 % or dyspnea grade III)

- Chronic heart failure stade III and IV (NYHA)

- History of recent acute coronary syndrome, unrelated to vasculitis