ExploriNg DUrable Remission with Rituximab in ANCA-associatEd vasculitis (ENDURRANCE trial): protocol for a...

Area of Science:

• Rheumatology
• Immunology
• Clinical Trials

Background:

• Antineutrophil cytoplasmic antibody-associated vasculitis (AAV) is a severe autoimmune disease.
• Rituximab (RTX) and cyclophosphamide (CYC) are standard remission induction therapies for AAV.
• RTX may offer a better long-term safety profile than CYC, but combination therapy data is limited.

Purpose of the Study:

• To investigate if RTX combined with low-dose CYC (RTX+LD-CYC) is superior to RTX alone for AAV remission induction.
• To assess if the combination therapy reduces the number of RTX retreatments needed to maintain clinical remission over two years.

Main Methods:

• An open-label, multicentre, randomized controlled trial involving 100 AAV patients with generalized disease.
• Patients randomized to receive either RTX alone or RTX+LD-CYC, both with steroids.
• Maintenance therapy with RTX, tailored to B-cell and ANCA status, for both groups over two years.

Main Results:

• Primary outcome: number of RTX retreatments required to maintain clinical remission over 2 years.
• Secondary outcomes: clinical endpoints, safety, quality of life, and immunological responses.
• Data on specific outcomes are pending trial completion.

Conclusions:

• The study aims to provide evidence on the efficacy and safety of RTX+LD-CYC versus RTX alone in AAV.
• Findings will inform optimal treatment strategies for AAV remission induction and maintenance.
• Results will be disseminated through peer-reviewed publications and conferences.