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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.
 
ClinicalTrials.gov Identifier: NCT04079920
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Rheumatoid Arthritis

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Study Type : Observational
Estimated 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 : September 22, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of Low Disease Activity (LDA) [ Time Frame: month 6 ]
    Percentage of participants with Disease Score Activity (DAS28) less than 3.2.

  2. Rate of remission [ Time Frame: month 6 ]
    Percentage of participants with a Disease Activity Score (DAS28) less than 2.6



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients presenting in outpatient clinics of Hospitals in Greece (secondary care)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079920


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Greece
University General Hospital of Athens "Attikon" Recruiting
Athens, Attiki, Greece, 12462
251 Air Force Hospital of Athens Recruiting
Athens, Greece, 11525
General Hospital of Athens Gennimatas Not yet recruiting
Athens, Greece
Laiko General Hospital of Athens Recruiting
Athens, Greece
Naval Hospital of Athens Recruiting
Athens, Greece
Nearchou 18 Recruiting
Crete, Greece
Univerisity General Hospital of Heraklion Recruiting
Heraklion, Greece
KAT General Hospital of Attica Recruiting
Kfisia, Greece
Univerisity General Hospital of Larisa Recruiting
Larisa, Greece, 41110
Univerisity General Hospital of Larisa Recruiting
Larisa, Greece
University General Hospital of Patras Recruiting
Patras, Greece, 26500
Agios Andreas General Hospital of Patra Recruiting
Patra, Greece
EUROMEDICA General Clinic of Thessaloniki Recruiting
Thessaloniki, Greece
Euromedica Kyanous Stavros General Clinic Recruiting
Thessaloniki, Greece
Asklipieio General Hospital of Voula Recruiting
Voula, Greece
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04079920    
Other Study ID Numbers: A3921342
TREAT-RA ( Other Identifier: Alias Study Number )
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases