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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02370550
Date of registration: 18/02/2015
Prospective Registration: Yes
Primary sponsor: Peking University People's Hospital
Public title: Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome CTRIPS
Scientific title: Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial
Date of first enrolment: March 2015
Target sample size: 240
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02370550
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
China
Contacts
Name:     Yue Yang, MD
Address: 
Telephone: +86-10-88325230
Email: yyang216@icloud.com
Affiliation: 
Name:     Yue Yang, MD
Address: 
Telephone: +86-10-88325230
Email:
Affiliation: 
Name:     Zhanguo Li, MD
Address: 
Telephone:
Email:
Affiliation:  Peking University People's Hospital
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Sjogren's Syndrome
Intervention(s)
Drug: Calcium carbonate D
Drug: Cyclosporin A
Drug: Placebo
Drug: Prednisone
Primary Outcome(s)
The forced vital capacity (FVC) [Time Frame: the 52 weeks]
Secondary Outcome(s)
The diffusing capacity of carbon monoxide (DLco) [Time Frame: the 52 weeks]
Secondary ID(s)
2014-M03
ChiCTR-IPR-15005990
U1111-1167-1974
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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