Sjogren's Syndrome
Conditions
Brief summary
The purpose of this large multicenter, randomized, double-blinded, controlled clinical study is to investigate the efficacy and safety of Cyclosporin A for primary Sjogren's syndrome associated pneumonitis(pSS-IP), which has important implications for the establishment of standardized diagnosis and treatment of pSS-IP.
Interventions
DRUGCyclosporin A
CsA 2-3 mg/kg/d, BID PO
DRUGPrednisone
Prednisone 0.5mg/kg/d QD PO starting at Week 0. After 2-4 weeks, the initial dose is gradually tapered by 2.5 mg each week until a maintenance dosage of 5-7.5 mg/d through week 52 (visit 6). The initial and maintenance doses are determined by the investigators of each center depending on the patients.
DRUGPlacebo
Placebo tablet 2-3 mg/kg/d, BID PO
DRUGCalcium carbonate D
Calcium carbonate D 600 mg, QD PO
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients meeting the 2002 or 2012 pSS criteria; * Patients meeting the diagnostic criteria of interstitial pneumonitis(IP); * Patients with exertional dyspnea consistent with grade 2 on the Magnitude of Task component of the Mahler Modified Dyspnea Index; * 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%; * For patients who received oral glucocorticoid, the doses should be no more than 10 mg/d (or equivalent amount of other types of glucocorticoids); * Patients who had not received any prior treatment with immunosuppressants (including but not limited to CYC, CsA, azathioprine(AZA), tacrolimus(FK-506), methotrexate, leflunomide, etc.) or had discontinued the therapy above for at least 3 months; for patients who received hydrochloroquine(HCQ), the doses should be stabilized for at least 3 months; * 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; * For patients who had prior treatment with N-acetylcysteine, the doses of above drugs should be stabilized for at least 3 months; * 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; * Patients who were able to read, to understand and to sign informed consent.
Exclusion criteria
Patients who met any of the following criteria will not participate in this study. * Patients with acute exacerbation of IP(AEIP); * Arterial blood gas analysis showed respiratory failure; * 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; * Patients with other rheumatic autoimmune diseases, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, primary biliary cirrhosis, etc.; * 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 ×109/L and/or hemoglobin (Hb) \<100 g/L and/or platelet (PLT) count \<80×109 /L; 5. Other serious diseases: such as cancer, etc.; * Patients with active infection or other diseases which will be aggravated with treatment of glucocorticoid and immunosuppressive therapy; * Patients positive for HBsAg or hepatitis C antibody; * Women during pregnancy or lactation, or cannot guarantee effective contraception; * Patients who did not cooperate with treatment for mental illness or other reasons; * Patients who had allergic constitution or were allergic to many drugs; * Patients who were allergic or intolerant to CsA, CYC, or glucocorticoid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The forced vital capacity (FVC) | the 52 weeks | The FVC is expressed as percent of expected values corrected baseline level. |
Secondary
| Measure | Time frame |
|---|---|
| The diffusing capacity of carbon monoxide (DLco) | the 52 weeks |
Countries
China
Contacts
Primary ContactYue Yang, MD
Outcome results
None listed