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The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tofacitinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib 5 MG | Drug | 5mg tofacitinib tablet twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's global assessment | a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points. | up to 12 weeks |
| Prurigo Activity Score | The PAS is a 7-item questionnaire evaluating the type, distribution and size of pruriginous lesions, the representative body area and exact number of lesions, the activity in the terms of percentage of pruriginous lesions with excoriations/crusts on top and the percentage of healed pruriginous lesions, which is proved to be a useful tool to objectively measure PN patients over time. | up to 12 weeks |
| Visual analogue scale (VAS) at week 12 | The VAS is a visual scale for itch on a horizontal 10-cm line, on which the left end is marked as "no itch" and the right end is marked "worst imaginable itch". We defined the average pruritus of the past 24 hours as VAS24h, average, and the worst and average pruritus of the past 4 weeks as VAS4w, worst and VAS4w, average. | up to 12 weeks |
| Numeric rating scale at week 12 | The NRS is a similar tool for the measurement of itch ranging from 0 (no itch) to 10 (unbearable itch). Similarly, we defined the average and worst pruritus of the past 24 hours using NRS as NRS24h, average and NRS24h, worst. | up to 12 weeks |
| Verbal rating scale (VRS) at week 12 | The VRS is a 5-point questionnaire that indicated different itching intensities as follows: 0=none; 1=mild; 2=moderate; 3=severe; 4= very severe. The VRS24h, average, VRS24h, worst and VRSevening represented 24-hour average, worst as well as average evening pruritus by VRS. | up to 12 weeks |
| Dermatology Life Quality Index (DLQI) at week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients with reduction in WI-NRS by ≥4 points from baseline at week 12 and week 16. | WI-NRS represents Worst Itch-Numeric Rating Scale score | up to 16 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru Dai | Contact | +8615982215914 | dairu@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University, China | Hangzhou | Zhejiang | 310009 | China |
The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
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Tofacitinib, an oral pan-JAK inhibitor, mainly selective against JAK1 and JAK3.
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The DLQI is a questionnaire with scores ranging from 0 to 30. The total scores of 30 points represent the worst possible quality of life due to pruritus and a change of the score of ≥4 points is considered to be clinically important. |
| up to 12 weeks |
| Itchy specific quality of life (Itchy QoL) at week 12 | The Itchy QoL includes 22 pruritus-specific items as follows: 6 symptoms, 7 functional limitation, and 9 emotions. | up to 12 weeks |
| D013568 | Pathological Conditions, Signs and Symptoms |