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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Basiliximab group | Experimental |
|
|
| control group | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basiliximab | Drug | The first administration should be within 8 weeks after disease onset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 52 week |
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity | measured with lung function test equipment | 52 week |
| Total lung capacity | measured with lung function test equipment |
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Inclusion Criteria:
(meet at least two in four of following)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Shanghai | Shanghai Municipality | 200001 | China |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D003882 | Dermatomyositis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017285 | Polymyositis |
| D009220 | Myositis |
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| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| D065095 | Calcineurin Inhibitors |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Calcineurin Inhibitors | Drug | 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. |
|
| Steroids | Drug | Dosage of steroid can be adjusted according to personal experience of the researcher. |
|
| 52 week |
| Diffusing capacity | transfer factor of the lung for carbon monoxide, measured with lung function test equipment. | 52 week |
| Lung CT change | Patient lung high resolution CT images will be semi-quantitatively assessed. Changes over baseline and endpoint will be then calculated. | 52 week |
| Serum ferritin | 52 week |
| Serum KL-6 | A new biomarker of alveolar injury. | 52 week |
| D009135 |
| Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |