Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 75 Years|
- - 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.
- - 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 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Peking University People's Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Zhanguo Li, MD|
|Principal Investigator Affiliation||Peking University People's Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Cyclosporin A(CsA)+glucocorticoid
A. The efficacy/safety are evaluated at V3, V4, V5 and V6, and the treatment is adjusted accordingly. Patients who experienced treatment failure (FVC absolute decrease >15% of predicted values after 4 weeks of treatment) are suggested to switch to intravenous glucocorticoid + cyclophosphamide(CYC) 0.5-1 g/m2 every 4 weeks as the rescue therapy after unblinding, and continue to complete the subsequent follow-up. Each patient can only have one chance to be rescued. Patients who experience a second treatment failure should be withdrawn from the trial and be given empirical treatment. Patients who did not experience treatment failure continued to receive current treatment. B. For subjects with aggravated shortness of breath and dyspnea in between of two consecutive visits, the investigators should decide whether a visit should be increased to complete subsequent examinations.
Placebo Comparator: placebo+glucocorticoid
A. The efficacy/safety are evaluated at V3, V4, V5 and V6, and the treatment is adjusted accordingly. Patients who experienced treatment failure are suggested to switch to glucocorticoid + CsA 2-3mg/kg/d, BID as the rescue therapy, and continue to complete the subsequent follow-up. Each patient can only have one chance to be rescued. Patients who did not experience treatment failure continued to receive current treatment. B. For subjects with aggravated shortness of breath and dyspnea in between of two consecutive visits, the investigators in each center should decide whether a visit should be increased.
Drug: - Cyclosporin A
CsA 2-3 mg/kg/d, BID PO
Drug: - Prednisone
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.
Drug: - Placebo
Placebo tablet 2-3 mg/kg/d, BID PO
Drug: - Calcium carbonate D
Calcium carbonate D 600 mg, QD PO
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.