Primary Sjogren's Syndrome Clinical Trial
Official title:
Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial
Primary Sjogren's syndrome (pSS) is an autoimmune disorder characterized by
keratoconjunctivitis sicca and xerostomia. In addition, various extraglandular
manifestations may develop. Several immunomodulating agents have been attempted in the
treatment of pSS without achieving satisfactory results. Currently, there is no approved
systemic treatment for pSS.
Mycophenolic acid (MPA) is a selective inhibitor of inosine-monophosphate-dehydrogenase
which leads to inhibition of the de novo pathway of nucleotide synthesis. The
antiproliferative effect of MPA mainly affects activated T- and B-lymphocytes because the
proliferation of these cells is critically dependent on the de novo purine synthesis
compared to other eukaryotic cells. Since these lymphocytes have been suggested to play a
pivotal role in the inflammation and immunopathogenesis of pSS, mycophenolate-sodium might
be a promising agent in the treatment of pSS.
We perform a single-centre, open-label pilot trial with Mycophenolate sodium in pSS.
Mycophenolic acid containing compounds such as mycophenolate mofetil and enteric coated
mycophenolate sodium are immunosuppressive drugs approved for the prevention of transplant
rejection. Mycophenolate mofetil (MMF) is an effective treatment in systemic lupus
erythematosus and other autoimmune diseases.
MMF has been used as maintenance therapy after treatment with rituximab (anti-CD20 antibody)
in a pSS patient. We have reported a case of successful treatment with MMF in pSS with
vasculitis.
The recent observations and the immunosuppressive effect of MPA in other autoimmune diseases
led us to evaluate the efficacy and safety of MPA treatment in patients with pSS refractory
to other immunosuppressive agents.
The observation period will be 6 months. At baseline, after 3, and after 6 months we examine
the clinical status including glandular function tests as well as different laboratory
parameters associated with pSS. In addition subjective parameters will be determined on the
basis of different questionnaires.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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