Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

Sponsor
Pfizer
Study ID
NCT04079920
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece. The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented. The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site

Key Dates

Start date
Sep 22, 2020
Status verified
Jun 2025
Primary completion
Feb 8, 2023
Completion
Feb 8, 2023

Study Design

Enrollment
198 participants (actual)

Primary Outcome Measure

Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) [ Time Frame: Month 6 ]

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