primary Sjogren's Syndrome
Conditions
Interventions
HCQ goup:Taking HCQ
cotrol goup:Nil
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patient with the ability to give informed, dated and signed consent before the beginning of any proceedings related to the trial; 2. Male and female aged of 18 or more; 3. Patient who is diagnosed with primary Sj?gren syndrome according to American/European consensus group (AECG) criteria (2002), and with positive serum auto-antibodies(ANA or anti SSA antibody); 4. Patients without treatment by hydroxychloroquine during 3 months preceding inclusion; 5. Disease duration no more than 5 years; 6. EULAR SS disease activity index (ESSDAI) no less than 3.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. lymphoma or other severe complications: interstitial lung fibrosis (area of interstitial lung disease more than 20% in HRCT, or FEV1 less than 75% in pulmonary function test); pulmonary arterial hypertension (pulmonary artery systolic pressure more than 45mmHg in ultrasonography test); glomerular disease associated with proteinuria >0.5 g/d, or renal tubular acidosis with abnormal renal function (Creatinine clearance =0.2 sec and QRS>=0.08 sec); 9. Risk of lost follow-up; 10. Psoriasis; 11. Hypersensitivity to chloroquine or to hydroxychloroquine or any of the other constituents of Plaquenil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI);EULAR Sjogren's syndrome disease activity index (ESSDAI); | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36; | — |
Countries
China
Contacts
Public ContactNiu Rui
Outcome results
None listed