Clinical trial NCT03981900: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-06-11
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Primary outcomes:
measure: Duration of Tofacitinib Drug Survival
timeFrame: Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)
Secondary outcomes:
measure: Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6 12, 18 and 24
measure: Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With Remission According to DAS28-4 ESR<2.6
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With Remission According to DAS28-4 CRP <2.6
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants in Remission According to SDAI <=3.3
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants in Remission According to CDAI<=2.8
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria
timeFrame: Baseline, Month 1, 3, 6, 12 18, and 24
measure: Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18, and 24
measure: Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18, and 24
measure: Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)
timeFrame: Month 1, 3, 6, 12, 18, and 24
measure: Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18, and 24
measure: Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18, and 24
measure: Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24
timeFrame: Month 1, 3, 6, 12, 18 and 24
measure: Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 1, 3, 6, 12, 18 and 24
measure: Number of Participants With Tofacitinib Tolerance Issue
timeFrame: Month 24
Other outcomes:
Locations:
city: Arras Cedex
country: France
facility: Centre Hospitalier D'arras
city: Aulnay Sous Bois
country: France
facility: Hopital Robert Ballanger
city: Aurillac
country: France
facility: Cabinet Medical
city: Auxerre
country: France
facility: Centre Hospitalier D Auxerre
city: Berck Sur Mer
country: France
facility: Institut Calot Helio Marin
city: Bobigny
country: France
facility: hopital Avicenne
city: Bourg en Bresse
country: France
facility: Centre Hospitalier de Fleyriat
city: Bourges
country: France
facility: Hopital Jacques Cœur
city: Brest
country: France
facility: Cabinet Medical
city: Brive La Gaillarde
country: France
facility: Cabinet Medical
city: Bruges
country: France
facility: Cabinet Medical
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougier
city: Caluire et Cuire
country: France
facility: Infirmerie Protestante de Lyon
city: Cannes
country: France
facility: Hopital Pierre Nouveau
city: Carcassonne
country: France
facility: Centre Hospitalier de Carcassonne
city: Clermont Ferrand
country: France
facility: Hopital Gabriel Montpied
city: Compiegne
country: France
facility: Centre Hospitalier de Compiegne
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dreux
country: France
facility: Hopital Victor Jousselin
city: Juvisy sur orge
country: France
facility: Centre Hospitalier des Deux Vallees Juvisy
city: La Battie Vieille
country: France
facility: Cabinet Medical
city: La Moutonne
country: France
facility: Cabinet Medical
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Vendee Les Oudairies
city: Le Bouscat
country: France
facility: Hopital Suburbain Du Bouscat
city: Le Bouscat
country: France
facility: Hopital Suburbain
city: Lille Cedex
country: France
facility: Hopital B Roger Salengro-chu De Lille
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro
city: Limoges
country: France
facility: Hopital Dupuytren
city: Limoges
country: France
facility: Cabinet Medical
city: Lyon Cedex 09
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Clinique de La Sauvegarde / Cabinet Le Trait D Union
city: Montauban
country: France
facility: Clinique du Pont de Chaume
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Montceau Les Mines
country: France
facility: Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri
city: Montivilliers
country: France
facility: Hopital Jacques Monod
city: Montpellier
country: France
facility: Cabinet Medical
city: Montpellier
country: France
facility: Cabinet Medical Saint Roch
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Montpellier
country: France
facility: Hopital Lapeyronie
city: Nimes
country: France
facility: Hopital Caremeau
city: Orleans
country: France
facility: Centre Hospitalier Orleans-Hopital La Source
city: Paris
country: France
facility: Cabinet Medical
city: Paris
country: France
facility: Centre Hospitalier Pitie Salpetriere
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Perigueux
country: France
facility: Centre Hospitalier de Perigueux
city: Pierre Benite Cedex
country: France
facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie
city: Poitiers
country: France
facility: Cabinet Medical
city: Poitiers
country: France
facility: Centre Hospitalier La Miletrie
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois Site Annecy
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Saint Lo
country: France
facility: Cabinet Medical
city: Saint Mande
country: France
facility: Hopital Inter-armees Begin
city: Saint Pierre
country: France
facility: Centre Hospitalier Universitaire Saint Pierre
city: Saint Priest En Jarez
country: France
facility: Centre Hospitalier Universitaire Saint Etienne Hopital Nord
city: Saint Priest en Jarez
country: France
facility: Hopital Nord
city: Tarbes
country: France
facility: Centre Hospitalier de Bigorre Site La Gespe
city: Toulouse
country: France
facility: Clinique Medipole Garonne
city: Toulouse
country: France
facility: Hopital Purpan
city: Toulouse
country: France
facility: Cabinet Medical
city: Tours
country: France
facility: Cabinet de Rhumatologie
city: Tours
country: France
facility: Cabinet Medical
city: Troyes
country: France
facility: Hopital des Hauts Clos
city: Valenciennes
country: France
facility: Cabinet Medical
city: Villeneuve Sur Lot
country: France
facility: Hopital Psv
city: Vincennes
country: France
facility: Cabinet Medical
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: