Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

NanoAlvand

Status: Completed

Conditions: Alopecia Areata(AA); Alopecia Totalis/Universalis

Treatments: Drug: Tofacitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT07101471

RHO.NA.SD.IV.99

Details and patient eligibility

About

The goal of this observational study is to evaluate safety of Rhofanib® (Tofacitinib) in male or female participants with the age of 18 years or older having clinical diagnosis of Alopecia. The main questions are aim to answer:

1. Is Rhofanib® (Tofacitinib) safe in Alopecia?
2. Is Rhofanib® (Tofacitinib) work to treat Alopecia?

In this study, there is no comparison group. Participants received Rhofanib® (Tofacitinib) with or without adjuvant prednisolone.

Full description

This study is a phase IV, post-marketing, observational, cohort study for the safety and effectiveness evaluation of Rhofanib® (Tofacitinib) use in Iranian participants with alopecia with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis.

Researchers and investigators gathered data in booklets. Exposure to Rhofanib® (Tofacitinib) in this study was defined as administration of Rhofanib® (Tofacitinib) with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.

The primary objective of this study was safety assessment, including the incidence of the most common adverse events (AEs), serious adverse events, and death during the study period.

The secondary objective is the effectiveness of Rhofanib® (Tofacitinib) by assessment of the Severity of Alopecia Tool (SALT) score, disease relapse (Patchy or complete scalp hair loss), eyebrow and eyelash status affected by alopecia, and also participants' quality of life-based on Dermatology life quality index (DLQI) during the study period.

This study was a single arm and the sample size of this study was 353 participants.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female with the age of 18 years or older
• Clinical diagnosis of alopecia areata with at least 40% scalp hair loss, alopecia totalis, or alopecia universalis who are prescribed Rhofanib®
• Stable or worsening disease for at least 6 months
• Patients who have given written authorization to use their personal health data for the purpose of this study.

Trial design

296 participants in 1 patient group

Participants received Rhofanib® (Tofacitinib)

Treatment:

Drug: Tofacitinib