Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis
Conditions
Brief summary
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.
Interventions
DRUGBasiliximab
The first administration should be within 8 weeks after disease onset.
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.
DRUGSteroids
Dosage of steroid can be adjusted according to personal experience of the researcher.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival | 52 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum ferritin | 52 week | — |
| Serum KL-6 | 52 week | A new biomarker of alveolar injury. |
| Lung CT change | 52 week | Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated. |
| Total lung capacity | 52 week | measured with lung function test equipment |
| Diffusing capacity | 52 week | transfer factor of the lung for carbon monoxide, measured with lung function test equipment. |
| Forced vital capacity | 52 week | measured with lung function test equipment |
Countries
China
Outcome results
None listed