Pretibial myxedema
Conditions
Interventions
Experimental group:Tofacitinib is taken orally
Sponsors
The First Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for PTM, and the history of PTM = 2%, mainly plaques, and no more than 5 nodules; (4) Signed informed consent; Willing and able to follow scheduled visits, treatment plans, laboratory tests, and other study procedures; (5) Stable thyroid disease in the past 3 months.
Exclusion criteria
Exclusion criteria: (1) Currently suffering from malignant tumors or having a history of malignant tumors (no more than 5 years after achieving complete remission after radical treatment); (2) subjects with acute or chronic psychiatric illness; (3) Positive for hepatitis B surface antigen at screening, or positive for hepatitis B core antibody (except for negative HBV DNA test or less than 500IU/ml); Positive hepatitis C virus antibody, positive human immunodeficiency virus (HIV) antibody, positive anti-syphilis pallidum antibody (TP-Ab positive, except for those who are negative for RPR or TRUST); (4) Active tuberculosis at screening (defined as: active tuberculosis based on clinical symptoms (such as fever, cough, night sweats, and weight loss), signs, tuberculosis laboratory tests (detected by ? interferon release assay, such as QFT or T-SPOT or other Mycobacterium tuberculosis detection experiments and/or imaging CT examinations)); or latent tuberculosis infection with isoniazid 0.3 g qd (or other prophylactic anti-tuberculosis therapy) for at least 4 weeks, and the investigators may consider continuing screening enrollment after re-assessing that the risk is controllable; ) (5) Presence of the following laboratory abnormalities: Hemoglobin (male) 2 times the upper limit of normal (ULN); Creatinine Cr>1.5×ULN; (6) there is a risk of major cardiovascular adverse events; (7) Treatment with glucocorticoids and calcineurin inhibitors in the past 7 days, oral glucocorticoids, methotrexate, cyclosporine or narrow-wave UVB irradiation in the past 4 weeks, and local occlusion therapy with glucocorticoids in the past 4 weeks; (8) Administration of any live vaccine within the last 4 weeks, or anticipated need for a live vaccine during study participation; (9) Females and/or males of childbearing potential and their partners who refuse to take effective contraceptive measures, or have childbearing, egg donation programs (females) or sperm donation programs (males) within 3 months from the time of signing the informed consent form to the last dose; (10) Female subjects with a positive pregnancy test or breastfeeding; (11) Use of any drugs that may interact with this product within 4 weeks before randomization, such as strong inhibitors of CYP3A4 (such as ketoconazole, itraconazole, clarithromycin, nefazodone, telithromycin, etc.), CYP2C19 strong inhibitors (such as fluconazole); (12) Thyroid surgery or radiation therapy in the 3 months prior to randomization and during medication; (13) History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation; (14) patients at higher risk of gastrointestinal perforation (e.g., patients with a history of diverticulitis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infiltrated area; | — |
Secondary
| Measure | Time frame |
|---|---|
| Erythema area;Calf circumference; | — |
Countries
China
Contacts
Public ContactSu Wang; Jianjun Qiao
The First Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed