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NCT Number: NCT00542763

Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome

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.

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Key information

Conditions

Primary Sjogren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mycophenolate sodium

Drug

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 names: Myfortic

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Collaborators

  • Novartis

Registry information

Official study title

Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial

Important dates

Study start
2005
Study completion
2007
First posted
Oct 11, 2007
Registry last updated
Oct 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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