Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients (TREAT-RA)

May 18, 2023 updated by: Pfizer

BASELINE VARIABLES PREDICTING TREATMENT RESPONSE AT 6 MONTHS IN ADULT RHEUMATOID ARTHRITIS PATIENTS TREATED WITH TOFACITINIB 5MG BID IN A NON-INTERVENTIONAL SETTING (TREAT - RA)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Laiko General Hospital of Athens
      • Athens, Greece, 11525
        • 251 Air Force Hospital of Athens
      • Athens, Greece
        • General Hospital of Athens Gennimatas
      • Athens, Greece
        • Ippokrateio General Hospital of Athens
      • Athens, Greece
        • Naval Hospital of Athens
      • Crete, Greece
        • Nearchou 18
      • Heraklion, Greece
        • Univerisity General Hospital of Heraklion
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina
      • Kfisia, Greece
        • KAT General Hospital of Attica
      • Larisa, Greece, 41110
        • Univerisity General Hospital of Larisa
      • Larisa, Greece
        • Univerisity General Hospital of Larisa
      • Patra, Greece
        • Agios Andreas General Hospital of Patra
      • Patras, Greece, 26500
        • University General Hospital of Patras
      • Thessaloniki, Greece
        • EUROMEDICA General Clinic of Thessaloniki
      • Thessaloniki, Greece
        • Euromedica Kyanous Stavros General Clinic
      • Thessaloniki, Greece
        • General Hospital of Thessaloniki Ippokrateio
      • Voula, Greece
        • Asklipieio General Hospital of Voula
    • Attiki
      • Athens, Attiki, Greece, 12462
        • University General Hospital of Athens "ATTIKON"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care)

Description

Inclusion Criteria:

  • Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label

    1. Patients aged ≥ 18 years
    2. Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist
    3. Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days .
    4. Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC).
    5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients meeting any of the following criteria will not be included in the study:

    1. Exclusion Criteria according to the Xeljanz® SmPC.
    2. Contraindications to Xeljanz® according to SmPC.
    3. Hypersensitivity to the active substance (tofacitinib) or to any of the excipients.
    4. Active tuberculosis (TB), serious infections, such as sepsis, or opportunistic infections.
    5. Receipt of any investigational drug within 3 months before study inclusion as well as currently not participating in an interventional clinical trial.
    6. Subjects who have received any previous treatment with tofacitinib or other JAK inhibitors.
    7. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Low Disease Activity (LDA)
Time Frame: month 6
Percentage of participants with Disease Score Activity (DAS28) less than 3.2.
month 6
Rate of remission
Time Frame: month 6
Percentage of participants with a Disease Activity Score (DAS28) less than 2.6
month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2020

Primary Completion (Actual)

February 8, 2023

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

August 5, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921342
  • TREAT-RA (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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