Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associate… (NCT03942887) | Clinical Trial Compass
UnknownPhase 3
Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
Netherlands100 participantsStarted 2019-05-03
Plain-language summary
Most recent insights in the treatment for patients with ANCA-associated vasculitis (AAV) have demonstrated that 'tailored' maintenance treatment with rituximab (RTX) is effective to achieve durable remission of disease. As such, RTX re-treatment can be tailored on the basis of relevant clinical and immunological parameters in AAV patients. Now, the present study intends to evaluate whether combining rituximab with cyclophosphamide is superior to current standard of care with rituximab only to induce a favorable clinical and immunological state in AAV patients and can thereby reduce the number of tailored re-treatments with rituximab.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Clinical diagnosis of granulomatosis with polyangiitis (GPA) or microscopic Polyangiitis (MPA), consistent with Chapel-Hill Consensus Conference definitions26
✓. Aged at least 18 years, with newly-diagnosed or relapsed AAV with 'generalised disease', defined as involvement of at least one major organ (e.g. kidney, lung, heart, peripheral or central nervous system), requiring induction treatment with cyclophosphamide or rituximab
✓. Positive test for anti-PR3 or anti-MPO (current or historic)
✓. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
Exclusion criteria
✕. Pregnant or breast-feeding
✕. Active pregnancy, as proven by a positive urine beta-HCG test or a positive serum beta-HCG
✕. Significant hypogammaglobulinemia (IgG \< 4.0 g/L) or an IgA deficiency (IgA \< 0.1 g/L)
✕. Active infection not compatible with start of remission-induction therapy in the opinion of the treating physician and/or investigator, e.g.: