Overview
Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome
Status:
Recruiting
Recruiting
Trial end date:
2021-12-01
2021-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Peking University People's HospitalTreatments:
Calcium
Calcium Carbonate
Cyclosporine
Cyclosporins
Glucocorticoids
Prednisone
Criteria
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.