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Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome (CTRIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02370550
Recruitment Status : Unknown
Verified May 2020 by Zhanguo Li, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2015
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Zhanguo Li, Peking University People's Hospital

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.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: Cyclosporin A Drug: Prednisone Drug: Placebo Drug: Calcium carbonate D Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Cyclosporin A
CsA 2-3 mg/kg/d, BID PO
Other Name: Cyclosporin A Capsules, CsA soft capsules 25 mg, Hangzhou China-US East China pharmaceutical Co., Ltd.

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: Calcium carbonate D
Calcium carbonate D 600 mg, QD PO

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: 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




Primary Outcome Measures :
  1. The forced vital capacity (FVC) [ Time Frame: the 52 weeks ]
    The FVC is expressed as percent of expected values corrected baseline level.


Secondary Outcome Measures :
  1. The diffusing capacity of carbon monoxide (DLco) [ Time Frame: the 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370550


Contacts
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Contact: Yue Yang, MD +86-10-88325230

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 110044
Contact: Yue Yang, MD    +86-10-88325230    yyang216@icloud.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li, MD Peking University People's Hospital
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Responsible Party: Zhanguo Li, Professor of Medicine, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT02370550    
Other Study ID Numbers: 2014-M03
U1111-1167-1974 ( Other Identifier: WHO ICTRP )
ChiCTR-IPR-15005990 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Pneumonia
Sjogren's Syndrome
Lung Diseases, Interstitial
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Cyclosporine
Prednisone
Calcium Carbonate
Calcium
Cyclosporins