Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients

NCT04079920

Last updated date
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Predictors of Response to Tofacitinib Treatment in Rheumatoid Arthritis Patients
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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 4, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2022
Estimated Primary Completion Date October 1, 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020