An interventional study of Tofacitinib 5 MG in Prurigo Nodularis and Itch, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
The goal is to evaluate the efficacy and safety of tofacitinib in treating refractory prurigo nodularis.The main questions it aims to answer are
Exclusion criteria:
Drug: Tofacitinib 5 MG
5mg tofacitinib tablet twice daily
Investigator's global assessment
a 11-point scale ranging from -5 (obvious aggravation) to 5(marked improvement) points.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 12 weeks
Dermatology Life Quality Index (DLQI) at week 12
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.
Time frame: 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.
Time frame: up to 12 weeks
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
Time frame: up to 16 weeks
Plan to share: No — 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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This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University