Sjogren's Syndrome Clinical Trial
Official title:
Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's Syndrome
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality of life in patients with Sjogren's syndrome. Mycophenolate also has excellent immunomodulation effects in lupus nephritis. Currently Mycophenolate is only used in lupus nephritis and organ transplant. It is unknown whether low dosage of mycophenolate mofetil could be used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
Sjogren's syndrome is one of the most common autoimmune diseases in Taiwan. It is
characterized by keratoconjunctivitis sicca and xerostomia. Although it is well established
that Sjogren's syndrome is caused by infiltration and destruction of lacrimal gland and
salivary gland by lymphocytic cells, effective treatment of patients' symptoms is lacking.
Hydroxychloroquine is the most well-studied medication in Sjogren's syndrome. However,
recent clinical trials showed disappointing effects of hydroxychloroquine in Sjogren's
syndrome. Thus there is an unmet need to find effective treatment for patient's bothering
symptoms.
Mycophenolate is a selective inhibitor of inosinemonophosphate dehydrogenase which leads to
inhibition of the de novo pathway of nucleotide synthesis. The antiproliferative effect of
mycophenolate mainly affects activated T and B lymphocytes because the proliferation of
these cells is critically dependent on the de novo purine synthesis compared with other
eukaryotic cells. Since these lymphocytes have been suggested to play a pivotal role in the
inflammation and immunopathogenesis of Sjogren's syndrome, mycophenolate might be a
promising agent in the treatment of Sjogren's syndrome.
Past literature showed encouraging effects of mycophenolate on dryness symptoms and quality
of life in patients with Sjogren's syndrome. Mycophenolate also has excellent
immunomodulation effects in lupus nephritis. Currently mycophenolate is only used in lupus
nephritis and organ transplant. It is unknown whether low dosage of mycophenolate could be
used to improve ocular dryness and oral dryness in patients with Sjogren's syndrome.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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