drug eruption
Conditions
Interventions
Therapy group:Adalimumab
Sponsors
The University of Hong Kong-Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years, no gender limit. 2. A drug eruption diagnosed according to guidelines and consistent with the type and severity of this test. During screening and baseline, the researchers were required to score the disease severity of each patient, including: (1) Itching index NRS score or pain index VAS score >=4; (2) The BSA score of skin lesion area should be >=3 points; (3) IGA score should be >=3 points; (4) Accompanied by systemic symptoms (fever) : body temperature >38?; (5) Inflammatory indicators: WBC exceeding the normal value or CRP exceeding 2 times the normal value; (6) Organ involvement (ALT or AST or Cr) more than 2 times the normal value; (7) Previous hormone therapy was not effective. Three or more eruption type drug eruptions could be included in this study; Severe drug eruption conforming to the type included in this study could be included in this study. 3. No history of active tuberculosis or family history, no history of hepatitis B, no history of tumor, no history of long-term use of hormones and immunosuppression before screening. 4. No hormone contraindications such as hypertension, diabetes and cerebral hemorrhage. 5. Negative pregnancy tests for women of childbearing age. 6. The patient and his/her spouse are willing to have no pregnancy plans or sperm donation plans for the next 6 months (i.e., 6 months after the trial medication), and voluntarily take effective contraceptive measures. 7. Volunteer to participate in clinical studies, be informed and sign informed consent, be willing to follow and be able to complete all trial procedures.
Exclusion criteria
Exclusion criteria: 1. Have received systemic treatment with corticosteroids or other immunosuppressive/immunomodulatory substances (such as cyclosporine, mycophenolate mofetil, azathioprine, methotrexate, etc.) for other diseases within 4 weeks before baseline; 2. Use local or systematic Chinese herbal medicine within 4 weeks before baseline; 3. Receive phototherapy (including but not limited to narrow-band UV-B, medium and large dose UVA1 treatment, etc.) that will affect the severity of the disease or interfere with the disease assessment within 4 weeks before the baseline and during the study period, or any treatment with luminous devices; 4. Other biological agents (such as TNF) have been used within 3 months before the baseline a antagonists); 5. Use of cell depleting agents (such as rituximab) within 6 months before baseline; 6. Subjects receiving allergen specific immunotherapy (SIT) within 6 months before baseline (except those who have been at a stable dose before baseline); 7. Other skin complications other than drug eruption may interfere with the study evaluation; 8. Have a history of malignant tumor within 5 years before screening; 9. Have serious cardiovascular and cerebrovascular disease or medical history, including but not limited to: history of serious heart disease, such as: history of symptomatic congestive heart failure (CHF) >= Grade 2 (CTCAE 5.0), history of NYHA cardiac function >= Grade II, history of transmural myocardial infarction, angina pectoris requiring medical treatment, etc; Various serious arrhythmias requiring drug treatment (except atrial fibrillation or paroxysmal supraventricular tachycardia), for example: male QTcF>450 msec or female QTcF>470 msec, complete left bundle branch block, third degree block; Hypertension with poor drug control (systolic blood pressure>160 mmHg and/or diastolic blood pressure>100 mmHg), or clinically significant vascular disease; 10. Those with clinically significant abnormalities in clinical examination, or with clinically significant diseases of various systems that are unstable or not well controlled [including but not limited to circulatory, digestive, respiratory, endocrine (including uncontrolled diabetes or thyroid diseases), urinary, nervous, blood, immune system diseases or mental diseases]; 11. Subjects with positive hepatitis B B HBsAg, positive hepatitis C antibody, syphilis infection or positive human immunodeficiency virus (HIV) antibody during previous screening, indicating active infection; 12. The subject shall be vaccinated with any live vaccine within 30 days before screening, or the subject plans to vaccinate with any live vaccine during the study period or within 1 month after the last administration of the study drug; 13. According to the investigator's judgment, it is known or suspected that there is a history of immunosuppression within 6 months before the baseline, including a history of invasive opportunistic infection, such as aspergillosis, coccidiosis, histoplasmosis, HIV, listeriosis, pneumocystis or tuberculosis, even if the infection has subsided; Or there is abnormal frequent recurrent or persistent infection; 14. Subjects who are addicted to alcohol, drugs and known drug dependence; 15. Subjects with active/severe concomitant diseases/symptoms (such as unstable chronic asthma, etc.) that may require systemic hormone therapy; 16. Those who are definitely allergic to this product or its preparation components; 17. Pregnant or lactating subjects, or subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGA score multiplied by lesion area reduction value;Incidence rate of adverse events;Incidence rate of adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time when the skin lesions began to improve; | — |
Countries
China
Contacts
Public ContactLiu Xiaoming
The University of Hong Kong-Shenzhen Hospital
Outcome results
None listed