From: Mycophenolate sodium treatment in patients with primary Sjögren syndrome: a pilot trial
Inclusion criteria | Diagnosis of primary Sjögren syndrome based on the American-European Consensus criteria [13] |
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Erythrocyte sedimentation rate of greater than 25 mm/hour and hypergammaglobulinemia (>1,500 mg/dL) | |
Presence of anti-SSA and/or SSB 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 Sjögren syndrome | |
History of cancer, severe infections, or other uncontrolled diseases | |
Treatment with concomitant disease-modifying antirheumatic drugs within the last 8 weeks before baseline evaluation | |
Prednisolone dose of greater than 5 mg/day or changes of prednisolone dose within the last 4 weeks before baseline | |
Use of secretagogues (for example, pilocarpine and civemeline) or medications that potentially diminish exocrine gland function (for example, tricyclic antidepressants and anticholinergic drugs) | |
Pregnant or lactating women |