Table 1.

Inclusion and exclusion criteria

Inclusion criteria	Diagnosis of primary Sjögren syndrome based on the American-European Consensus criteria [13]
	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