Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04079920
Collaborator
(none)
200
Enrollment
18
Locations
24.2
Anticipated Duration (Months)
11.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    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)
    Actual Study Start Date :
    Sep 22, 2020
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Rate of Low Disease Activity (LDA) [month 6]

      Percentage of participants with Disease Score Activity (DAS28) less than 3.2.

    2. Rate of remission [month 6]

      Percentage of participants with a Disease Activity Score (DAS28) less than 2.6

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University General Hospital of Athens "Attikon" Athens Attiki Greece 12462
    2 251 Air Force Hospital of Athens Athens Greece 11525
    3 General Hospital of Athens Gennimatas Athens Greece
    4 Ippokrateio General Hospital of Athens Athens Greece
    5 Laiko General Hospital of Athens Athens Greece
    6 Naval Hospital of Athens Athens Greece
    7 Nearchou 18 Crete Greece
    8 Univerisity General Hospital of Heraklion Heraklion Greece
    9 University General Hospital of Ioannina Ioannina Greece 45500
    10 KAT General Hospital of Attica Kfisia Greece
    11 Univerisity General Hospital of Larisa Larisa Greece 41110
    12 Univerisity General Hospital of Larisa Larisa Greece
    13 University General Hospital of Patras Patras Greece 26500
    14 Agios Andreas General Hospital of Patra Patra Greece
    15 EUROMEDICA General Clinic of Thessaloniki Thessaloniki Greece
    16 Euromedica Kyanous Stavros General Clinic Thessaloniki Greece
    17 General Hospital of Thessaloniki Ippokrateio Thessaloniki Greece
    18 Asklipieio General Hospital of Voula Voula Greece

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04079920
    Other Study ID Numbers:
    • A3921342
    • TREAT-RA
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Feb 22, 2022