Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - Full Text View

Sponsor:	University Hospital Muenster
Collaborator:	Novartis
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00542763

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 I

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

Resource links provided by NLM:

MedlinePlus related topics: Sjogren's Syndrome

Drug Information available for: Mycophenolic acid Mycophenolate sodium Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

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:

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

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542763

Locations

Germany
University Hospital Muenster
Muenster, NRW, Germany, 48129

Sponsors and Collaborators

University Hospital Muenster

Novartis

Investigators

Principal Investigator:

Markus Gaubitz, MD

University Hospital Muenster

More Information

Publications:

Mavragani CP, Moutsopoulos NM, Moutsopoulos HM. The management of Sjogren's syndrome. Nat Clin Pract Rheumatol. 2006 May;2(5):252-61. Review.

Gaubitz M, Schorat A, Schotte H, Kern P, Domschke W. Mycophenolate mofetil for the treatment of systemic lupus erythematosus: an open pilot trial. Lupus. 1999;8(9):731-6.

Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. Review.

Willeke P, Domschke W, Gaubitz M: Mycophenolate Mofetil for the treatment of primary Sjogren's Syndrome: A case report. Ann Rheum Dis, 62 (Suppl. 1):352,2003

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
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases

Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012