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Войти в исследования Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial.
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Snijders Romée J A L M, Stoelinga Anna E C, Gevers Tom J G, Pape Simon, Biewenga Maaike, Verdonk Robert C, de Jonge Hendrik J M, Vrolijk Jan Maarten, Bakker Sjoerd F, Vanwolleghem Thomas, de Boer Ynto S, Pronk Martine A M C Baven, Beuers Ulrich H W, van der Meer Adriaan J, van Gerven Nicole M F, Sijtsma Marijn G M, Verwer Bart J, Gisbertz Ingrid A M, Bartelink Maartje, van den Brand Floris F, Sebib Korkmaz Kerem, van den Berg Aad P, Guichelaar Maureen M J, Soufidi Khalida, Levens Amar D, van Hoek Bart, Drenth Joost P H, Dutch Autoimmune Hepatitis Working Group
Аннотация
METHODS: CAMARO is a randomised (1:1), open-label, parallel-group, multicentre superiority trial. All patients with AIH are screened for eligibility. Seventy adult patients with AIH from fourteen centres in the Netherlands and Belgium will be randomised to receive MMF or azathioprine. Both treatment arms will start with prednisolone as induction therapy. The primary outcome is biochemical remission, defined as serum levels of alanine aminotransferase and immunoglobulin G below the upper limit of normal. Secondary outcomes include safety and tolerability of MMF and azathioprine, time to remission, changes in Model For End-Stage Liver Disease (MELD)-score, adverse events, and aspects of quality of life. The study period will last for 24 weeks.
DISCUSSION: The CAMARO trial investigates whether treatment with MMF and prednisolone increases the proportion of patients in remission compared with azathioprine and prednisolone as the current standard treatment strategy. In addition, we reflect on the challenges of conducting a randomized trial in rare diseases.
TRIAL REGISTRATION: EudraCT 2016-001038-91 . Prospectively registered on 18 April 2016.