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

Willeke et al. Arthritis Research & Therapy 2007 9:R115   doi:10.1186/ar2322

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