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RemiRit - Personalized immunosuppressive therapy with rituximab in the treatment of ANCA associated vasculitis - a randomized, multicenter clinical trial
EU CTIS ID: 2024-517881-40-00
What this study is testing
Part I - induction treatment: Comparison of the efficacy of combination treatment with rituximab (RTX) and cyclophosphamide (CYC) versus standard treatment with cyclophosphamide (CYC) in induction of complete remission of severe AAV, defined as BVAS/WG=0. Part II - maintenance treatment: To compare the efficacy of subcutaneous and intravenous rituximab (RTX) treatment in sustaining complete (BVAS/WG=0) or partial (BVAS/WG=1 or2) remission of AAV. Additional research objective: To evaluate genetic predisposition to disease development, disease course, and response to treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent of the patient to participate in the clinical trial.
- Consent to prophylactically intake of Entecavir in case of a positive total anti-Hbc result with HBsAg.
- Age ≥ 18 years.
- Diagnosis of AAV, including granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) as defined by the Chapel Hill Consensus Conference.
- New diagnosis or exacerbation of AAV.
- High AAV activity defined as ≥ 3 points on the BVAS/WG scale.
You likely can't join if
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) as defined by the Chapel Hill Consensus Conference.
- Positive pregnancy test performed among women of childbearing age at screening or Visit 1.
- Medications being taken: a. Rituximab and other drugs that cause B-lymphocyte depletion within 6 months prior to screening, b. Cyclophosphamide within 6 months prior to screening, except when oral cyclophosphamide is included up to 7 days prior to screening and discontinued no later than the day of screening, c. Infliximab within 3 months prior to screening, d. Adalimumab within 2 months prior to screening, e. Etanercept within 1 month prior to screening.
- Acute or chronic respiratory failure, not due to AAV.
- Documented history of antichimeric antibody formation after administration of monoclonal antibodies.
- Diagnosis of AAV limited to the kidney, without involvement of other organs.
See the full eligibility criteria
Who can join
- Written informed consent of the patient to participate in the clinical trial.
- Consent to prophylactically intake of Entecavir in case of a positive total anti-Hbc result with HBsAg.
- Age ≥ 18 years.
- Diagnosis of AAV, including granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) as defined by the Chapel Hill Consensus Conference.
- New diagnosis or exacerbation of AAV.
- High AAV activity defined as ≥ 3 points on the BVAS/WG scale.
- Positive PR3-ANCA or MPO-ANCA at screening or within 30 days prior to screening.
- Discontinuation of current immunosuppressive and immunomodulatory agents, including mycophenolate mofetil, azathioprine, methotrexate and leflunomide, no later than the day of screening.
- Use of highly effective contraception by women of childbearing potential during the study and 12 months after the last administration of the investigational medicinal product.
- Use of high barrier contraception by men with female partners of childbearing potential throughout the study and 6 months after the last administration of an investigational medicinal product.
What rules you out
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) as defined by the Chapel Hill Consensus Conference.
- Positive pregnancy test performed among women of childbearing age at screening or Visit 1.
- Medications being taken: a. Rituximab and other drugs that cause B-lymphocyte depletion within 6 months prior to screening, b. Cyclophosphamide within 6 months prior to screening, except when oral cyclophosphamide is included up to 7 days prior to screening and discontinued no later than the day of screening, c. Infliximab within 3 months prior to screening, d. Adalimumab within 2 months prior to screening, e. Etanercept within 1 month prior to screening.
- Acute or chronic respiratory failure, not due to AAV.
- Documented history of antichimeric antibody formation after administration of monoclonal antibodies.
- Diagnosis of AAV limited to the kidney, without involvement of other organs.
- Diagnosis of AAV with simultaneous presence of both MPO-ANCA and PR3-ANCA antibodies in serum.
- Limited form of disease that does not require treatment with cyclophosphamide.
- Respiratory failure due to diffuse alveolar hemorrhage requiring mechanical ventilation.
- Diagnosis of disease associated with anti-glomerular basement membrane (anti-GBM) as defined by the Chapel Hill Consensus Conference.
- Active or history of cancer within the past 5 years, except for basal-cell carcinoma of the skin and carcinoma in situ of cervix in patients who have received radical treatment.
- Severe heart failure (New York Heart Association Class IV) or severe uncontrolled heart disease not due to AAV.
- Infections: a. Active and chronic viral, bacterial, fungal or parasitic infection b. Active or latent tuberculosis c. Active or chronic hepatitis B d. Active or chronic hepatitis C e. Diagnosed HIV infection.
- History of severe allergic reactions to human or chimeric monoclonal antibodies or mouse proteins.
- History of hypersensitivity to the active substance or any excipient of the investigational medicinal products (cyclophosphamide or rituximab).
- History of intolerance to any of the investigational medicinal products (cyclophosphamide or rituximab).
- History of allergy to drugs or other substances which, in the opinion of the Investigator is a contraindication to participation in the study.
- Abuse of drugs, alcohol or other intoxicating substances.
- Vaccination with live vaccines within 4 weeks prior to screening.
- Pregnancy or planning a pregnancy during the study and 12 months after the study.
- Breastfeeding or planning to breastfeed during the study and 12 months after completion of the study.
- Participation in another clinical trial.
- Acute or chronic liver disease, not due to AAV, which in the opinion of the Investigator is a contraindication to participation in the study.
- Lack of patient compliance.
- History or presence of other relevant diseases that, in the opinion of the Investigator may adversely affect the patient's participation in the study.
- Congenital or acquired immunodeficiency.
- Current history of urinary tract obstruction.
- History of hemorrhagic cystitis, bone marrow hypoplasia or malignancy during treatment with cyclophosphamide.
- Bone marrow aplasia.
- Screening findings: a. Leukopenia defined as a white blood cell (WBC) count below 4000/mm3, b. Neutropenia defined as a neutrophil count less than 1500/mm3, c. Thrombocytopenia defined as a platelet count (PLT) less than 100000/mm3, d. Hemoglobin (Hgb) less than 8.0 g/dl, e. AST or ALT elevations greater than 2.5 x GGN, not due to AAV, f. Severe immunoglobulin deficiency defined as IgG less than 400 mg/dL or IgA less than 10 mg/dL, g. Positive HBsAg, h. Positive anti-HCV result, i. Positive QuantiFERON-TB Gold test result, j. Positive anti-HIV 1 or anti-HIV 2
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.