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Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00542763
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : October 11, 2007
Information provided by:
University Hospital Muenster

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Sjogren's Syndrome Drug: Mycophenolate sodium Phase 1

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial
Study Start Date : April 2005
Actual Study Completion Date : September 2007

Intervention Details:
  • Drug: Mycophenolate sodium
    Medical treatment is initiated with one tablet of 360 mg mycophenolate sodium orally per day for eligible patient. The dosage will be increased weekly by 360 mg up to a maximum stable dose of 1440mg daily. In patients not well tolerating the drug the dosage can be reduced to 720 mg per day.
    Other Name: Myfortic

Primary Outcome Measures :
  1. Efficacy of mycophenolate sodium for sicca syndrome and changes in laboratory values associated with the disease [ Time Frame: Basline, week 12 and week 24 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00542763

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University Hospital Muenster
Muenster, NRW, Germany, 48129
Sponsors and Collaborators
University Hospital Muenster
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Principal Investigator: Markus Gaubitz, MD University Hospital Muenster
Layout table for additonal information Identifier: NCT00542763    
Other Study ID Numbers: myf-01-049
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: October 11, 2007
Last Verified: August 2004
Keywords provided by University Hospital Muenster:
Sjogren's syndrome
Mycophenolate sodium
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action