Chronic urticaria
Conditions
Interventions
Tofacitinib groups:None
Antihistamine group:None
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. aged 16-65 years; 2. gender is unlimited; 3. cholinergic urticaria or artificial urticaria is diagnosed according to the Chinese urticaria diagnosis and treatment guidelines (2022 version), specifically: it is diagnosed according to the symptoms of typical wheal with pruritus and / or angioedema, and can be collected according to the condition, and examined and diagnosed by dermatology specialties such as visual inspection and palpation. If the cause of urticaria is clear, other laboratory tests may not be necessary, otherwise provocation or threshold tests can be used for diagnosis. Note: cholinergic urticaria provocation test: (1) exercise provocation test: exercise with fitness bike, treadmill and other fitness equipment for 30min, and wheal during exercise or within 10min after exercise is a positive diagnostic test; If the exercise provocation test is positive, it is recommended to conduct the temperature provocation test at an interval of more than 24h. (2) . Artificial urticaria provocation test: (1) scratch test: gently scratch the forearm or upper back skin with a smooth blunt object or a special test instrument. The diagnosis test is positive if there is a wheal and itch at the scratch after 10min. The minimum stimulation intensity causing the above symptoms is the threshold. 4. cholinergic urticaria or artificial urticaria were diagnosed for >= 2 months at baseline, and urticaria accompanied by pruritus occurred for >= 6 weeks after using 2 or more standard doses of H1 antihistamines at any time before baseline (the baseline period was defined as the period of >= 12 weeks after starting continuous use of tofacitinib or combined (3-4) / doubled dose / replacement of H1 antihistamines). 5. baseline uct = 3 months, or antihistamines combined (3-4 kinds) / doubled dose / changed type >= 3 months.
Exclusion criteria
Exclusion criteria: 1. There are any diseases that need to be avoided mentioned in the drug instructions, including those allergic to tofacitinib, those with serious active infection (including HIV infection, hepatitis B, hepatitis C, tuberculosis, etc.), those with increased risk of thrombosis, those with absolute lymphocyte count less than 500 cells /mm, those with absolute neutrophil count (ANC) less than 1000 cells /mm, and those with low hemoglobin level (i.e. less than 9g/dl). 2. Immunosuppressive therapy was administered simultaneously 4 weeks before baseline or within 5 half lives, whichever was longer; 3. Omalizumab in the last 3 months; 4. Intravenous or subcutaneous immunoglobulin therapy, plasma exchange, or inactive or live attenuated vaccines within 30 days before baseline; 5. Doxepin was used within 14 days before baseline; 6. Use of H2 antihistamines within 7 days prior to baseline; 7. Leukotriene antagonists used within 7 days before baseline or systemic corticosteroids used within 14 days before baseline; 8. Other types of urticaria as the main forms of morbidity include: chronic spontaneous urticaria, cold induced urticaria, heat induced urticaria, solar urticaria, pressure urticaria, delayed pressure urticaria, water or contact urticaria. If cholinergic urticaria or artificial urticaria is the main form of chronic urticaria, these diseases are allowed as comorbidities; 9. There are any other active skin diseases related to chronic itch that may confound the study evaluation and results (such as atopic dermatitis, bullous pemphigoid, herpetic dermatitis, etc.); 10. There are any other diseases that hinder the follow-up or data interpretation, or the follow-up may damage the safety of patients; 11. Avoid live vaccination and tofacitinib administration at the same time, and the interval between live vaccination and the start of tofacitinib treatment should conform to the current vaccination guidelines on immunosuppressive drugs; 12. There are any other conditions that do not allow the completion of clinical trials, such as the use of illegal drugs or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in Urticaria Control Test (UCT) relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients achieving complete response (CR), clinically meaningful response (CMR), and partial response ;Change in Cholinergic Urticaria Severity Index (CholUSI) from baseline;Change in Visual Analog Scale (VAS) from baseline;Change in Cholinergic Urticaria Quality-of-Life Questionnaire (CholU-QoL) from baseline;Change in Critical Friction Thresholds (CFT) from baseline ;Change in Chronic Urticaria Quality-of-Life Questionnaire (CU-Q2oL) from baseline;Change in Dermatology Life Quality Index (DLQI) from baseline; | — |
Countries
China
Contacts
Public ContactSuyun Ji
Dermatology Hospital of Southern Medical University
Outcome results
None listed