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

Pfizer

Status

Completed

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Tofacitinib

Study type

Observational

Funder types

Industry

Identifiers

NCT03981900

A3921313

DeFacTo (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

314 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.