Observational study;Mycophenolate sodium (Myfortic) in primary Sjogren’s syndrome.

Completed

Conditions: 1. Sjogren's syndrome
 2. Mycophenolate sodium
 3. Sicca syndrome
 4. Immunosuppression.

Lead Sponsor: Professor Dr. Markus GaubitzMuenster University ClinicAlbert Schweitzer Sreet 3348129 Muenster Germanygaubitz@uni-muenster.deTel: +49-251-8357562

Brief Summary: 1. 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, 8:731-736; 2. Willeke P, Domschke W, Gaubitz M: Mycophenolate Mofetil for the treatment of primary Sjögren's Syndrome: A case report. Ann Rheum Dis 2003, 62 (Suppl. 1) :352; 3. Mavragani CP, Moutsopoulos NM, Moutsopoulos HM: The management of Sjogren's syndrome. Nat Clin Pract Rheumatol 2006, 2:252-261.

Recruitment & Eligibility

Inclusion Criteria

1. Diagnosis of primary Sjogren's syndrome based on the American-European Consensus criteria (Vitali et al.);

2. Erythrocyte sedimentation rate >25mm/h and hypergammaglobulinemia (>1500 mg/dl);

Exclusion Criteria

1. Age below 18 or above 75 years;

2. Pregnant or lactating women;

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of mycophneolate sodium treatment in patients with pSS refractory to other immunosuppressive agents. <br /><br>Outcome measures: <br /><br>Glandular function tests, questionnaires, and laboratory tests at baseline, after 4 weeks, week 12, at week 24. <br /><br>The lachrymal gland function will be assessed by unanesthetized Schirmer’s test.<br /><br>In addition, we will collected and weighed the unstimulated whole saliva throughout 5 minutes. <br /><br>Visual analoge scale for the severity of ocular dryness, arthralgia, and fatigue on a 100-mm visual analogue scale (VAS) ranging from 0 to 100.<br /><br>Outcome will also be determined by the Short Form-36 (SF-36). In addition, the Health Assessment Questionnaire (HAQ) has to be completed <br>Levels of immunoglobulins (IgG, IgM and IgA), RF-IgM as well as serum concentrations of complement levels (C3 and C4) will be measured during the trial. Also IgG antibodies to SS-A and SS-B will be analysed.

Secondary Outcome Measures

Name	Time	Method
Safety of mycophenolate sodium treatment in patients with pSS: <br /><br>Outcome measures: <br /><br>History-taking including, clinical examination.<br /><br>At each clinical visit, the patients will be asked about possible adverse events. <br /><br>Laboratory tests at baseline, after 4 weeks, week 12, at week 24.(i.e. ESR, C-reactive protein (CRP), renal and liver function tests, total protein, and full blood count). <br>