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

NCT03981900

Last updated date
Study Location
Centre Hospitalier D'arras
Arras Cedex, , 62022, France
Contact
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

- 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.

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Advanced Information
Descriptive Information
Brief Title IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
Official Title IDentification 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with a diagnosis of moderate to severe active rheumatoid arthritis for whom the rheumatologist has decided to initiate a treatment with Tofacitinib
Condition Arthritis, Rheumatoid
Intervention Drug: Tofacitinib
5 mg BID, oral administrtaion
Other Name: Xeljanz
Study Groups/Cohorts Rheumatoid 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 Status Recruiting
Estimated Enrollment
 (submitted: June 7, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2023
Estimated Primary Completion Date January 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
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 France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03981900
Other Study ID Numbers A3921313
DeFacTo ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
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/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