IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
NCT ID: NCT03981900
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
314 participants
OBSERVATIONAL
2019-01-04
2023-02-06
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rheumatoid arthritis
All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib
Tofacitinib
5 mg BID, oral administrtaion
Tofacitinib
tablet form 11mg once daily oral
Interventions
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Tofacitinib
5 mg BID, oral administrtaion
Tofacitinib
tablet form 11mg once daily oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Centre Hospitalier D'arras
Arras, , France
Hopital Robert Ballanger
Aulnay-sous-Bois, , France
Cabinet Medical
Aurillac, , France
Centre Hospitalier D Auxerre
Auxerre, , France
Institut Calot Helio Marin
Berck, , France
hopital Avicenne
Bobigny, , France
Centre Hospitalier de Fleyriat
Bourg-en-Bresse, , France
Hopital Jacques Cœur
Bourges, , France
Cabinet Medical
Brest, , France
Cabinet Medical
Brive-la-Gaillarde, , France
Cabinet Medical
Bruges, , France
Centre Hospitalier Jean Rougier
Cahors, , France
Infirmerie Protestante de Lyon
Caluire-et-Cuire, , France
Hopital Pierre Nouveau
Cannes, , France
Centre Hospitalier de Carcassonne
Carcassonne, , France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalier de Compiegne
Compiègne, , France
Hopital Henri Mondor
Créteil, , France
Hopital Victor Jousselin
Dreux, , France
Centre Hospitalier des Deux Vallees Juvisy
Juvisy-sur-Orge, , France
Cabinet Medical
La Battie Vieille, , France
Cabinet Medical
La Moutonne, , France
Centre Hospitalier Departemental Vendee Les Oudairies
La Roche-sur-Yon, , France
Hopital Suburbain Du Bouscat
Le Bouscat, , France
Hopital Suburbain
Le Bouscat, , France
Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro
Lille, , France
Hopital B Roger Salengro-chu De Lille
Lille, , France
Hopital Dupuytren
Limoges, , France
Cabinet Medical
Limoges, , France
Clinique de La Sauvegarde / Cabinet Le Trait D Union
Lyon, , France
Clinique de la Sauvegarde
Lyon, , France
Clinique du Pont de Chaume
Montauban, , France
Centre Hospitalier de Montauban
Montauban, , France
Centre Hospitalier Montceau Les Mines-Hopital Jean Bouveri
Montceau-les-Mines, , France
Hopital Jacques Monod
Montivilliers, , France
Cabinet Medical
Montpellier, , France
Cabinet Medical Saint Roch
Montpellier, , France
Clinique Beau Soleil
Montpellier, , France
Hopital Lapeyronie
Montpellier, , France
Hopital Caremeau
Nîmes, , France
Centre Hospitalier Orleans-Hopital La Source
Orléans, , France
Cabinet Medical
Paris, , France
Centre Hospitalier Pitie Salpetriere
Paris, , France
Hopital Cochin
Paris, , France
Hopital Bichat Claude Bernard
Paris, , France
Centre Hospitalier de Perigueux
Périgueux, , France
Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie
Pierre-Bénite, , France
Cabinet Medical
Poitiers, , France
Centre Hospitalier La Miletrie
Poitiers, , France
Centre Hospitalier Annecy Genevois Site Annecy
Pringy, , France
Hopital Charles Nicolle
Rouen, , France
Cabinet Medical
Saint-Lô, , France
Hopital Inter-armees Begin
Saint-Mandé, , France
Centre Hospitalier Universitaire Saint Pierre
Saint-Pierre, , France
Centre Hospitalier Universitaire Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
Hopital Nord
Saint-Priest-en-Jarez, , France
Centre Hospitalier de Bigorre Site La Gespe
Tarbes, , France
Clinique Medipole Garonne
Toulouse, , France
Hopital Purpan
Toulouse, , France
Cabinet Medical
Toulouse, , France
Cabinet de Rhumatologie
Tours, , France
Cabinet Medical
Tours, , France
Hopital des Hauts Clos
Troyes, , France
Cabinet Medical
Valenciennes, , France
Hopital Psv
Villeneuve-sur-Lot, , France
Cabinet Medical
Vincennes, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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DeFacTo
Identifier Type: OTHER
Identifier Source: secondary_id
A3921313
Identifier Type: -
Identifier Source: org_study_id
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