Basiliximab Treating Interstitial Pneumonia of CADM
NCT03192657 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-06-20
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.
Conditions
- Lung; Disease, Interstitial, With Fibrosis
- Dermatomyositis
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.
Sponsors & Collaborators
-
RenJi Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-31
- Primary Completion
- 2019-06-30
- Completion
- 2020-06-30
Countries
- China
Study Locations
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