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

Study Overview
=================
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

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.

Conditions
-----------------
Arthritis, Rheumatoid

Intervention / Treatment
-----------------
* Drug: Tofacitinib
* Drug: Tofacitinib


Participation Criteria
=================
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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rheumatoid arthritis<br>All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib | Drug: Tofacitinib<br>* 5 mg BID, oral administrtaion<br>* Other names: Xeljanz;Drug: Tofacitinib<br>* tablet form 11mg once daily oral<br>* Other names: Xeljanz;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Tofacitinib survival | Tofacitinib maintenance will be estimated by considering the date of initiation of treatment with Tofacitinib and the date of permanent discontinuation of this same treatment. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in catastrophising behaviour adopted by the participant | Evaluate by the change from baseline of the PCS-Pain Catastrophising Scale at different time point | Baseline, month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in coping adaptative strategy adopted by the participant | Evaluate by the change from baseline of the CSQ-Coping Strategies Questionnaire score at different time point | Baseline, month 1, 3, 6, 12, 18 and 24 | 
| Percentage of participants with low disease activity (LDA) | Low disease activity assessed by DAS28-4 ESR/CRP < 3.2, SDAI ≤ 11, CDAI ≤ 10 | Month 1, 3, 6, 12, 18 and 24 | 
| Percentage of participants in remission | Remission assessed by DAS28-4 ESR/CRP < 2.6, SDAI ≤ 3.3, CDAI ≤ 2.8, ACR-EULAR 2011 Boolean criteria (TJC ≤ 1 + SJC ≤ 1 + CRP ≤ 1 mg/dL + VAS patient ≤ 1 cm) | Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in score DAS28 ESR/CRP and in its components over time | DAS28 ESR/CRP score and in its components over time | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Evaluation of response to treatment considering outcome of the DAS28 (EULAR criteria) | Response to treatment evaluated by the DAS28 UELAR criteria | Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in the number of painful joints (TJC) over time | Number of painful joint count scored between 0 to 28 | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in the number of swollen joints (SJC) over time | Number of swollen joint count scored between 0 to 28 | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Evaluation of the possible existence of fibromyalgia | Fibromyalgia evaluated by the FiRST questionnaire | Baseline, month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in the duration of morning stiffness over time | Moring stiffness scored in minutes | Baseline, month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in patient compliance over time (GIRERD Questionnaire) | Compliance measured by the GIRERD questionnaire | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in overall health status over time (EuroQoL EQ-5D-3L questionnaire) | Health status evaluated by the EuroQoL EQ-5D-3L questionnaire | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in quality of life over time | Quality of life over time evaluated by the SF-12 questionnaire | Baseline, Month 1, 3, 6, 12, 18 and 24 | 
| Change from baseline in fatigue over time | Fatigue scored by the FACIT-Fatigue questionnaire | Baseline, Month 1, 3, 6, 12, 18 and 24 |