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Inclusion and exclusion criteria |
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| 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 |
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| Requirement of artificial teardrops due to symptomatic sicca syndrome |
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| Inadequate response or intolerance of prior treatment with hydroxychloroquine and/or azathioprine |
|
| Adequate contraception for females of childbearing potential |
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| Exclusion criteria |
Age below 18 or above 75 years |
| Secondary Sjögren syndrome |
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| History of cancer, severe infections, or other uncontrolled diseases |
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| Treatment with concomitant disease-modifying antirheumatic drugs within the last 8 weeks before baseline evaluation |
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| Prednisolone dose of greater than 5 mg/day or changes of prednisolone dose within the last 4 weeks before baseline |
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| Use of secretagogues (for example, pilocarpine and civemeline) or medications that potentially diminish exocrine gland function (for example, tricyclic antidepressants and anticholinergic drugs) |
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| Pregnant or lactating women |
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Willeke et al. Arthritis Research & Therapy 2007 9:R115 doi:10.1186/ar2322 |
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