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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    500
  • sponsor
    Pfizer
Updated on 12 October 2020
tofacitinib

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.

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

Details
Treatment tofacitinib
Clinical Study IdentifierNCT03981900
SponsorPfizer
Last Modified on12 October 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Rheumatoid Arthritis (Pediatric) or Rheumatoid Arthritis?
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 of 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
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