IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
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.
2 other identifiers
observational
314
1 country
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2019
CompletedFirst Submitted
Initial submission to the registry
June 7, 2019
CompletedFirst Posted
Study publicly available on registry
June 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2023
CompletedResults Posted
Study results publicly available
October 1, 2024
CompletedOctober 1, 2024
June 1, 2024
4.1 years
June 7, 2019
June 5, 2024
June 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of Tofacitinib Drug Survival
The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.
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 (23)
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24
Baseline, Month 1, 3, 6, 12, 18 and 24
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24
Baseline, Month 1, 3, 6 12, 18 and 24
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)
Baseline, Month 1, 3, 6, 12 18, and 24
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)
Baseline, Month 1, 3, 6, 12 18, and 24
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11
Baseline, Month 1, 3, 6, 12 18, and 24
- +18 more secondary outcomes
Study Arms (1)
Rheumatoid arthritis
All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib
Interventions
Eligibility Criteria
Patients with a diagnosis of moderate to severe active rheumatoid arthritis for whom the rheumatologist has decided to initiate a treatment with Tofacitinib
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (66)
Centre Hospitalier D'arras
Arras, 62022, France
Hopital Robert Ballanger
Aulnay-sous-Bois, 93602, France
Cabinet Medical
Aurillac, 15000, France
Centre Hospitalier D Auxerre
Auxerre, 89011, France
Institut Calot Helio Marin
Berck, 62600, France
hopital Avicenne
Bobigny, 93009, France
Centre Hospitalier de Fleyriat
Bourg-en-Bresse, 01012, France
Hopital Jacques Cœur
Bourges, 18020, France
Cabinet Medical
Brest, 29200, France
Cabinet Medical
Brive-la-Gaillarde, 19100, France
Cabinet Medical
Bruges, 33520, France
Centre Hospitalier Jean Rougier
Cahors, 46005, France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69641, France
Hopital Pierre Nouveau
Cannes, 06414, France
Centre Hospitalier de Carcassonne
Carcassonne, 11010, France
Hopital Gabriel Montpied
Clermont-Ferrand, 63003, France
Centre Hospitalier de Compiegne
Compiègne, 60321, France
Hopital Henri Mondor
Créteil, 94010, France
Hopital Victor Jousselin
Dreux, 28102, France
Centre Hospitalier des Deux Vallees Juvisy
Juvisy-sur-Orge, 91265, France
Cabinet Medical
La Battie Vieille, 05000, France
Cabinet Medical
La Moutonne, 83260, France
Centre Hospitalier Departemental Vendee Les Oudairies
La Roche-sur-Yon, 85925, France
Hopital Suburbain Du Bouscat
Le Bouscat, 33110, France
Hopital Suburbain
Le Bouscat, 33491, France
Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro
Lille, 59037, France
Hopital B Roger Salengro-chu De Lille
Lille, 59037, France
Hopital Dupuytren
Limoges, 87042, France
Cabinet Medical
Limoges, 87100, France
Clinique de La Sauvegarde / Cabinet Le Trait D Union
Lyon, 69009, France
Clinique de la Sauvegarde
Lyon, 69337, France
Clinique du Pont de Chaume
Montauban, 82000, France
Centre Hospitalier de Montauban
Montauban, 82013, France
Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri
Montceau-les-Mines, 71307, France
Hopital Jacques Monod
Montivilliers, 76290, France
Cabinet Medical
Montpellier, 34000, France
Cabinet Medical Saint Roch
Montpellier, 34070, France
Clinique Beau Soleil
Montpellier, 34070, France
Hopital Lapeyronie
Montpellier, 34295, France
Hopital Caremeau
Nîmes, 30029, France
Centre Hospitalier Orleans-Hopital La Source
Orléans, 45067, France
Cabinet Medical
Paris, 75008, France
Centre Hospitalier Pitie Salpetriere
Paris, 75651, France
Hopital Cochin
Paris, 75679, France
Hopital Bichat Claude Bernard
Paris, 75877, France
Centre Hospitalier de Perigueux
Périgueux, 24019, France
Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie
Pierre-Bénite, 69495, France
Cabinet Medical
Poitiers, 86000, France
Centre Hospitalier La Miletrie
Poitiers, 86021, France
Centre Hospitalier Annecy Genevois Site Annecy
Pringy, 74374, France
Hopital Charles Nicolle
Rouen, 76031, France
Cabinet Medical
Saint-Lô, 50000, France
Hopital Inter-armees Begin
Saint-Mandé, 94163, France
Centre Hospitalier Universitaire Saint Pierre
Saint-Pierre, 97410, France
Centre Hospitalier Universitaire Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Centre Hospitalier de Bigorre Site La Gespe
Tarbes, 65013, France
Clinique Medipole Garonne
Toulouse, 31036, France
Hopital Purpan
Toulouse, 31059, France
Cabinet Medical
Toulouse, 31400, France
Cabinet de Rhumatologie
Tours, 37000, France
Cabinet Medical
Tours, 37000, France
Hopital des Hauts Clos
Troyes, 10003, France
Cabinet Medical
Valenciennes, 59322, France
Hopital Psv
Villeneuve-sur-Lot, 47305, France
Cabinet Medical
Vincennes, 94300, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer Inc.
- Organization
- Pfizer ClinicalTrials.gov Call Center
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2019
First Posted
June 11, 2019
Study Start
January 4, 2019
Primary Completion
February 6, 2023
Study Completion
February 6, 2023
Last Updated
October 1, 2024
Results First Posted
October 1, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share
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/data\_requests.