1. Sjogren's syndrome
Conditions
Interventions
The dosage of mycophenolate sodium shoud increase weekly by 360mg up to a maximum stable dose of 1440 mg daily. In patients not well tolerating the drug the dosage can be reduced to 720 mg per day.
Fo
Sponsors
Professor Dr. Markus Gaubitz
Muenster University Clinic
Albert Schweitzer Sreet 33
48129 Muenster
Germany
gaubitz@uni-muenster.de
Tel: +49-251-8357562
Eligibility
Inclusion criteria
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); 3. Presence of anti-SS-A and /or SS-B antibodies and/or rheumatoid factor; 4. Requirement of artificial teardrops due to symptomatic sicca syndrome; 5. Adequate contraception for females of childbearing potential; 6. Inadequate response or intolerance of prior treatment with hydroxychloroquine and/or azathioprine.
Exclusion criteria
Exclusion criteria: 1. Age below 18 or above 75 years; 2. Pregnant or lactating women; 3. Secondary Sjogren’s syndrome; 4. History of cancer, severe infections or other uncontrolled diseases; 5. Treatment with concomitant disease modifying anti-rheumatic drugs within the least 4 weeks before baseline evaluation; 6. Prednisolone dose of >5mg/d or changes of prednisolone dose within the least 4 weeks before baseline; 7. Use of secretagogues (e.g. pilocarpine, civemeline) or medications that potentially diminish exocrine gland function (e.g. tricyclic antidepressants, anti-cholinergic drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of mycophneolate sodium treatment in patients with pSS refractory to other immunosuppressive agents. Outcome measures: Glandular function tests, questionnaires, and laboratory tests at baseline, after 4 weeks, week 12, at week 24. The lachrymal gland function will be assessed by unanesthetized Schirmer’s test. In addition, we will collected and weighed the unstimulated whole saliva throughout 5 minutes. 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. Outcome will also be determined by the Short Form-36 (SF-36). In addition, the Health Assessment Questionnaire (HAQ) has to be completed 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
| Measure | Time frame |
|---|---|
| Safety of mycophenolate sodium treatment in patients with pSS: Outcome measures: History-taking including, clinical examination. At each clinical visit, the patients will be asked about possible adverse events. 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). | — |
Contacts
Public ContactPeter Willeke
Muenster University Clinic Albert Schweitzer Sreet 33
Outcome results
None listed