Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial |
- Efficacy of mycophenolate sodium for sicca syndrome and changes in laboratory values associated with the disease [ Time Frame: Basline, week 12 and week 24 ]
- Safety of mycophenolate sodium in patients with primary Sjogren's syndrome: Clinical examination, full blood count, renal function tests, liver function tests [ Time Frame: basline, after week 4, 12, and week 24 ]
| Enrollment: | 12 |
| Study Start Date: | April 2005 |
| Study Completion Date: | September 2007 |
-
Drug: Mycophenolate sodium
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of primary Sjogren' Syndrome based on the American-European Consensus criteria
- Erythrocyte sedimentation rate >25mm/h and hypergammaglobulinemia (>1500 mg/dl)
- Presence of anti-SS-A and /or SS-B antibodies and / or rheumatoid factor
- Requirement of artificial teardrops due to symptomatic sicca syndrome
- Inadequate response or intolerance of prior treatment with hydroxychloroquine and / or azathioprine
- Adequate contraception for females of childbearing potential
Exclusion Criteria:
- Age below 18 or above 75 years
- Secondary Sjogren's syndrome
- History of cancer, severe infections or other uncontrolled diseases
- Treatment with concomitant disease modifying anti-rheumatic drugs within the least 8 weeks before baseline evaluation
- Prednisolone dose of > 5mg/d or changes of prednisolone dose within the least 4 weeks before baseline
- Use of secretagogues (e.g. pilocarpine, cevimeline) or medications that potentially diminish exocrine gland function (e.g. tricyclic antidepressants, anti-cholinergic drugs)
- Pregnant or lactating women
Contacts and Locations| Germany | |
| University Hospital Muenster | |
| Muenster, NRW, Germany, 48129 | |
| Principal Investigator: | Markus Gaubitz, MD | University Hospital Muenster |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00542763 History of Changes |
| Other Study ID Numbers: | myf-01-049 |
| Study First Received: | October 10, 2007 |
| Last Updated: | October 10, 2007 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by University Hospital Muenster:
|
Sjogren's syndrome Mycophenolate sodium |
Additional relevant MeSH terms:
|
Sjogren's Syndrome Dry Eye Syndromes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Lacrimal Apparatus Diseases Eye Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Mycophenolic Acid Mycophenolate mofetil Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013