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Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial
- Source :
- Trials, 23(1):1012. BioMed Central Ltd., Trials, 23(1):1012. BioMed Central, TRIALS, 23(1):1012. BMC, on behalf of the Dutch Autoimmune Hepatitis Working Group 2022, ' Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial) : study protocol for a randomised controlled trial ', Trials, vol. 23, no. 1, 1012 . https://doi.org/10.1186/s13063-022-06890-w, Trials, Trials, 23(1). BMC, Trials, 23, 1, Trials, 23(1). BioMed Central Ltd, Trials, 23
- Publication Year :
- 2022
- Publisher :
- BMC, 2022.
-
Abstract
- Background Currently, the standard therapy for autoimmune hepatitis (AIH) consists of a combination of prednisolone and azathioprine. However, 15% of patients are intolerant to azathioprine which necessitates cessation of azathioprine or changes in therapy. In addition, not all patients achieve complete biochemical response (CR). Uncontrolled data indicate that mycophenolate mofetil (MMF) can induce CR in a majority of patients. Better understanding of first-line treatment and robust evidence from randomised clinical trials are needed. The aim of this study was to explore the potential benefits of MMF as compared to azathioprine, both combined with prednisolone, as induction therapy in a randomised controlled trial in patients with treatment-naive AIH. 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. Graphical Abstract
- Subjects :
- Adult
Remission
Immunosuppressive Agents/adverse effects
First-line treatment
Medicine (miscellaneous)
Autoimmune hepatitis
Biochemical remission
Severity of Illness Index
Prednisolone/adverse effects
Induction therapy
Hepatitis
End Stage Liver Disease
SDG 3 - Good Health and Well-being
Azathioprine
Humans
Multicenter Studies as Topic
Pharmacology (medical)
Hepatitis, Autoimmune/diagnosis
Randomized Controlled Trials as Topic
Phase IV trial
Mycophenolate mofetil
Mycophenolic Acid/adverse effects
Azathioprine/adverse effects
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11]
Treatment Outcome
Randomized controlled trial
Autoimmune/diagnosis
Quality of Life
Human medicine
Subjects
Details
- Language :
- English
- ISSN :
- 17456215
- Database :
- OpenAIRE
- Journal :
- Trials, 23(1):1012. BioMed Central Ltd., Trials, 23(1):1012. BioMed Central, TRIALS, 23(1):1012. BMC, on behalf of the Dutch Autoimmune Hepatitis Working Group 2022, ' Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial) : study protocol for a randomised controlled trial ', Trials, vol. 23, no. 1, 1012 . https://doi.org/10.1186/s13063-022-06890-w, Trials, Trials, 23(1). BMC, Trials, 23, 1, Trials, 23(1). BioMed Central Ltd, Trials, 23
- Accession number :
- edsair.doi.dedup.....2f268f0c5f0c5d471147b4cc9c9b0876