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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04079920
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : July 20, 2021
Information provided by (Responsible Party):

Tracking Information
First Submitted Date August 5, 2019
First Posted Date September 6, 2019
Last Update Posted Date July 20, 2021
Actual Study Start Date September 22, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2019)
  • Rate of Low Disease Activity (LDA) [ Time Frame: month 6 ]
    Percentage of participants with Disease Score Activity (DAS28) less than 3.2.
  • Rate of remission [ Time Frame: month 6 ]
    Percentage of participants with a Disease Activity Score (DAS28) less than 2.6
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
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

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care)
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 4, 2019)
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contact: Pfizer Call Center 1-800-718-1021
Listed Location Countries Greece
Removed Location Countries  
Administrative Information
NCT Number NCT04079920
Other Study ID Numbers A3921342
TREAT-RA ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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:
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date July 2021