Rhofanib® (Tofacitinib) Safety and Effectiveness Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-04

Study Completion Date

2025-06-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tofacitnib for the Treatment of Alopecia Areata and Variants

NCT02197455

Alopecia Areata (AA) Alopecia Totalis (AT) Alopecia Universalis (AU)

COMPLETED PHASE2

Effectiveness and Safety of Tofacitinib in Patients With Extensive and Recalcitrant Alopecia Areata

NCT03800979

Alopecia Areata

COMPLETED PHASE4

Tofacitinib for the Treatment of Alopecia Areata and Its Variants

NCT02312882

Alopecia Areata Alopecia Totalis Alopecia Universalis

COMPLETED NA

Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

NCT03315689

Alopecia Universalis (AU) Alopecia Totalis (AT)

COMPLETED PHASE2

Study To Evaluate The Efficacy Of Tofacitinib In Moderate To Severe Alopecia Areata, Totalis And Universalis

NCT02299297

Alopecia Areata

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alopecia Totalis/Universalis Alopecia Areata(AA)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Participants received Rhofanib® (Tofacitinib)

Tofacitinib

Intervention Type DRUG

Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tofacitinib

Tofacitinib with a suggested dose of 5 mg twice daily with or without adjuvant prednisolone.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No