Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University Hospital Muenster Novartis |
---|---|
Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00542763 |
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.
Condition | Intervention | Phase |
---|---|---|
Primary Sjogren's Syndrome |
Drug: Mycophenolate sodium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial |
Enrollment: | 12 |
Study Start Date: | April 2005 |
Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, NRW | |
University Hospital Muenster | |
Muenster, NRW, Germany, 48129 |
Principal Investigator: | Markus Gaubitz, MD | University Hospital Muenster |
Study ID Numbers: | myf-01-049 |
Study First Received: | October 10, 2007 |
Last Updated: | October 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00542763 |
Health Authority: | Germany: Ethics Commission |
Sjogren's syndrome Mycophenolate sodium |
Mouth Diseases Autoimmune Diseases Joint Diseases Eye Diseases Mycophenolic Acid Arthritis, Rheumatoid Lacrimal Apparatus Diseases Dry Eye Syndromes Rheumatic Diseases |
Xerostomia Musculoskeletal Diseases Arthritis Mycophenolate mofetil Connective Tissue Diseases Sjogren's Syndrome Stomatognathic Diseases Salivary Gland Diseases |
Disease Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses |