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 |
|
