Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome

NCT00542763 | Completed Phase 1

• 1 other identifier: myf-01-049
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjogren's Syndrome

Keywords

Sjogren's syndrome; Mycophenolate sodium

Outcome Measures

Primary Outcomes (1)

• Efficacy of mycophenolate sodium for sicca syndrome and changes in laboratory values associated with the disease

  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

  basline, after week 4, 12, and week 24

Interventions

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.

Also known as: Myfortic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Muenster: lead
• Novartis: collaborator

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48129, Germany

Location

Related Publications (4)

• Mavragani CP, Moutsopoulos NM, Moutsopoulos HM. The management of Sjogren's syndrome. Nat Clin Pract Rheumatol. 2006 May;2(5):252-61. doi: 10.1038/ncprheum0165.

  PMID: 16932698 BACKGROUND

• 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. doi: 10.1191/096120399678840927.

  PMID: 10602445 BACKGROUND

• 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. doi: 10.1136/ard.61.6.554.

  PMID: 12006334 BACKGROUND

• Willeke P, Schotte H, Schluter B, Erren M, Becker H, Dyong A, Mickholz E, Domschke W, Gaubitz M. Interleukin 1beta and tumour necrosis factor alpha secreting cells are increased in the peripheral blood of patients with primary Sjogren's syndrome. Ann Rheum Dis. 2003 Apr;62(4):359-62. doi: 10.1136/ard.62.4.359.

  PMID: 12634239 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Markus Gaubitz, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: April 1, 2005
• Study Completion: September 1, 2007
• Last Updated: October 11, 2007

Record last verified: 2004-08

Locations

DE (1)