Sjogren's syndrome
Conditions
Interventions
Treatment group:glucocorticoid+CsA
Control group:glucocorticoid+placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-75 years; (2) Patients meeting the 2002 or 2012 pSS criteria (see appendix 2); (3) Patients meeting the diagnostic criteria of IP (see appendix 3); (4) Patients with exertional dyspnea consistent with grade 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index (see appendix 4); (5) Pulmonary function test: patients with percentages of forced vital capacity (FVC) to predicted values >=45%, percentage of diffusing capacity of carbon monoxide (DLCO) to predicted values >=30%, forced expiratory volume in one second (FEV1) / FVC >65%; (6) For patients who received oral glucocorticoid, the doses should be no more than 10 mg/d (or equivalent amount of other types of glucocorticoids); (7) Patients who had not received any prior treatment with immunosuppressants (including but not limited to CYC, CsA, AZA, FK-506, methotrexate, leflunomide, etc.) or had discontinued the therapy above for at least 3 months; for patients who received HCQ, the doses should be stabilized for at least 3 months; (8) Patients who had not received any prior treatment with biological agents, including but not limited to rituximab, infliximab, adalimumab, etanercept, etc., or had discontinued therapy for at least three months; (9) For patients who had prior treatment with N-acetylcysteine, the doses of above drugs should be stabilized for at least 3 months; (10) The women of reproductive age who had a negative urine pregnancy test. The women and men of reproductive age must receive effective contraceptive measures from the screening period to last administration of drugs; (11) Patients who were able to read, to understand and to sign informed consent.
Exclusion criteria
Exclusion criteria: Patients who met any of the following criteria will not participate in this study: 1. Patients with acute exacerbation of IP (AEIP)(See appendix 5); 2. Arterial blood gas analysis showed respiratory failure; 3. Patients with lung diseases other than IP: (1) Patients with severe pulmonary hypertension who require specific treatments assessed by the rheumatology and immunology experts in various clinical centers; (2) Patients with a history of smoking within the last 6 months or current smokers; (3) Patients with other serious lung diseases, such as lung tumor or active pulmonary infection; (4) Lung biopsy, alveolar lavage or high-resolution computerized tomography (HRCT) suggested serious lung diseases other than IP; 4. Patients with other rheumatic autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, primary biliary cirrhosis, etc.; 5. Patients with serious heart, liver, kidney diseases, hematologic and/ or endocrine diseases: (1) Heart diseases: decompensated heart failure or refractory hypertension; clinically important abnormal ECG that may lead to unacceptable risks to enrolled patients at screening; (2) Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >=2 times the upper limit of normal (ULN); (3) Renal function: renal tubular and/or interstitial diseases, renal insufficiency: serum creatinine >=2 ULN or glomerular filtration rate (eGFR) <90 ml/min/1.73 m2; (4) White blood cell (WBC) count <3 *10^9/L and/or hemoglobin (Hb) <100 g/L and/or platelet (PLT) count <80*10^9/L; (5) Other serious diseases: such as cancer, etc.; 6. Patients with active infection or other diseases which will be aggravated with treatment of glucocorticoid and immunosuppressive therapy; 7. Patients positive for HBsAg or hepatitis C antibody; 8. Women during pregnancy or lactation, or cannot guarantee effective contraception; 9. Patients who did not cooperate with treatment for mental illness or other reasons; 10. Patients who had allergic constitution or were allergic to many drugs; 11. Patients who were allergic or intolerant to CsA, CYC, or glucocorticoid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FVC; | — |
Secondary
| Measure | Time frame |
|---|---|
| DLco;VC;TLC;FEV1;lung HRCT score;PaO2;P(A-a)CO2;incidence of AEIP;6MWT;D-12 score;ESSPRI;SF-36;ESR;CRP;Ig A/G/M;complement;ANA;anti-SSA Ab;anti-SSB Ab;KL-6, KL-10;SPD;MCP-13;IFNr;IL-1b;TNFa; | — |
Countries
China
Contacts
Public ContactZhanguo Li, Yue Yang
Outcome results
None listed