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Basiliximab Treating Interstitial Pneumonia of CADM

Study Purpose

This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type 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.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.

- Agreement of contraception.

- Serum creatine Kinase ≤ 1.5 fold of upper normal level.

- Interstitial pneumonia: (meet at least two in four of following) 1.

interstitial pneumonia images in high resolution CT; 2. DLCO (diffusing capacity)≤ 60% predict in lung function test; 3. elevated serum KL-6; 4. serum anti-MDA5 (+).

Exclusion Criteria:

- Previous application of immunosuppressives or any target treatment for dermatomyositis.

- Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).

- Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.

- Abnormal renal function at screening (serum creatine＞300μmol/L，or eGFR＜60mL/min/1.73m2, or end-stage renal disease).

- Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.

- History of any malignancy.

Trial Details

Trial ID: 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.	NCT03192657
Phase 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.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	RenJi Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis

Arms & Interventions

Arms

Experimental: Basiliximab group

Basiliximab: 20mg injection each time at day1 and day5, respectively. The first administration should be within 8 weeks after disease onset. Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. Steroids: 1mg/kg/d, calculated with prednisone.

Active Comparator: control group

Calcineurin inhibitors: cyclosporin A 3-5mg/kg/d or tacrolimus 0.05-0.10mg/kg/d. Steroids: 1mg/kg/d, calculated with prednisone.

Interventions

Drug: - Basiliximab

The first administration should be within 8 weeks after disease onset.

Drug: - Calcineurin Inhibitors

Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.

Drug: - Steroids

Dosage of steroid can be adjusted according to personal experience of the researcher.

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.

International Sites

RenJi Hospital, Shanghai, Shanghai, China

Status

Address

RenJi Hospital

Shanghai, Shanghai, 200001