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IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

Last updated on October 9, 2019

FOR MORE INFORMATION
Study Location
Cabinet Medical
Aurillac, , 15000 France
Contact
1-800-718-1021
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

- Patient 18 years of age or older

- Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has
been confirmed by a rheumatologist

- Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib

- Patient informed and consented to participate to the study

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

- Patient participating in a randomised clinical trial.

- Patient presenting with a contraindication to prescription of Tofacitinib

- Patients who are investigational site staff members or patients who are Pfizer
employees directly involved in the conduct of the trial.

NCT03981900
Pfizer
Recruiting
IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

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Descriptive Information
Brief TitleIDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Official TitleIDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.
Brief Summary

Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available.

Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA.

As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

Detailed Description

This is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of Tofacitinib's survival in patients with rheumatoid arthritis

If catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. It has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease.

Therefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

The duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period.

Patients will be followed prospectively and follow-up visits will be conducted after the initial consultations. No visit or additional test is required by the protocol, since the study is observational

Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients with a diagnosis of moderate to severe active rheumatoid arthritis for whom the rheumatologist has decided to initiate a treatment with Tofacitinib
ConditionArthritis, Rheumatoid
InterventionDrug: Tofacitinib
5 mg BID, oral administrtaion
Other Name: Xeljanz
Study Groups/CohortsRheumatoid arthritis
All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib
Intervention: Drug: Tofacitinib
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 StatusRecruiting
Estimated Enrollment
 (submitted: June 7, 2019)
500
Original Estimated EnrollmentSame as current
Estimated Study Completion DateJanuary 31, 2023
Estimated Primary Completion DateJanuary 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient 18 years of age or older
  • Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist
  • Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib
  • Patient informed and consented to participate to the study

Exclusion Criteria:

  • Patient participating in a randomised clinical trial.
  • Patient presenting with a contraindication to prescription of Tofacitinib
  • Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesFrance
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03981900
Other Study ID NumbersA3921313
DeFacTo ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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