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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
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

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.

Trial ID:
NCT03192657

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
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
RenJi Hospital

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
N/A
Principal Investigator Affiliation N/A

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Not yet recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis

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

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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