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Discontinuation of rituximab compared with rituximab maintenance in ANCA-associated vasculitis – a randomized non-blinded controlled trial (DISRITUX)
EU CTIS ID: 2023-508398-10-00
What this study is testing
The primary objective is to study the relapse rate after discontinuation of rituximab compared with rituximab maintenance in ANCA-associated vasculitis (AAV) patients in stable remission
- Therapeutic use (Phase IV)
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
- Informed consent given by patient according to national regulations
- AAV [granulomatosis with polyangiitis or microscopic polyangiitis], according to the definitions of the Chapel Hill Consensus Conference
- Current or history of PR3/MPO-ANCA positivity by ELISA
- A stable remission (BVAS =0) for the last 24 months
- Has received a minimum of 24 months of RTX maintenance therapy and last dose minimum 6 months prior to screening. A Rituximab dose of 500 mg or 1000 mg 6 months before inclusion will be accepted
- Females of childbearing potential must agree to avoid pregnancy during treatment with RTX during 12 months after discontinuation of RTX. They also must have a negative urine or serum pregnancy test at the screening visit. Adequate contraception methods must be followed according to clinical routine for these patients
You likely can't join if
- Significantly abnormal eGFR at screening (≤15 eGFR ml/min/1.73m2)
- Hypogammaglobulinemia, IgG <3 g/L
- History of malignancy within the past five years or any evidence of persistent malignancy. Fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure is allowed
- Females who are lactating or pregnant at screening (verified with a negative urine or serum pregnancy test at screening visit).
- Medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- Participant in another clinical trial with therapeutic intervention or use of any other investigational agent
See the full eligibility criteria
Who can join
- Informed consent given by patient according to national regulations
- AAV [granulomatosis with polyangiitis or microscopic polyangiitis], according to the definitions of the Chapel Hill Consensus Conference
- Current or history of PR3/MPO-ANCA positivity by ELISA
- A stable remission (BVAS =0) for the last 24 months
- Has received a minimum of 24 months of RTX maintenance therapy and last dose minimum 6 months prior to screening. A Rituximab dose of 500 mg or 1000 mg 6 months before inclusion will be accepted
- Females of childbearing potential must agree to avoid pregnancy during treatment with RTX during 12 months after discontinuation of RTX. They also must have a negative urine or serum pregnancy test at the screening visit. Adequate contraception methods must be followed according to clinical routine for these patients
What rules you out
- Significantly abnormal eGFR at screening (≤15 eGFR ml/min/1.73m2)
- Hypogammaglobulinemia, IgG <3 g/L
- History of malignancy within the past five years or any evidence of persistent malignancy. Fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure is allowed
- Females who are lactating or pregnant at screening (verified with a negative urine or serum pregnancy test at screening visit).
- Medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- Participant in another clinical trial with therapeutic intervention or use of any other investigational agent
- Previous therapy with any of the following: - any biological B cell depleting agent other than rituximab during the last 6 months (i.e Obinutuzumab, Belimumab) - IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months - any investigational agent within 28 days of screening, or 5 half-lives of the investigational drug (whichever is longer)
- Ongoing therapy with any of the following. - disease modifying therapy related for AAV such as methotrexate, azathioprine, and mycophenolate mofetil or glucocorticoid >5 mg daily
- Recurrent AAV relapses less than 6 months off immunosuppressive medication
- Significant or uncontrolled medical disease not related to AAV, which in the investigator’s opinion would preclude patient participation
- Presence of another multisystem autoimmune disease, including Churg Strauss syndrome, systemic lupus erythematosus, anti-GBM disease, or cryoglobulinaemic vasculitis
- History of severe allergic or anaphylactic reactions to humanized or murine chimeric monoclonal antibodies
- Past or current history of hepatitis B virus, current active hepatitis C
- Bone marrow suppression as evidenced by a total white count < 3.0 x109/l and/or neutropenia neutrophil count < 1.5 × 109
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
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.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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.