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NCT03981900 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03981900
Other study ID # A3921313
Secondary ID DeFacTo
Status Completed
Phase
First received
Last updated
Start date January 4, 2019
Est. completion date February 6, 2023

Study information
Verified date April 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 314
Est. completion date February 6, 2023
Est. primary completion date February 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tofacitinib
5 mg BID, oral administrtaion
• Tofacitinib
tablet form 11mg once daily oral

Locations
Country Name City State
France Centre Hospitalier D'arras Arras Cedex
France Hopital Robert Ballanger Aulnay Sous Bois
France Cabinet Medical Aurillac
France Centre Hospitalier D Auxerre Auxerre
France Institut Calot Helio Marin Berck Sur Mer
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 Compiegne
France Hopital Henri Mondor Creteil
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 Le Bouscat
France Hopital Suburbain Du Bouscat Le Bouscat
France Centre Hospitalier Universitaire de Lille - Hopital B Roger Salengro Lille
France Hopital B Roger Salengro-chu De Lille Lille Cedex
France Cabinet Medical Limoges
France Hopital Dupuytren Limoges
France Clinique de La Sauvegarde / Cabinet Le Trait D Union Lyon
France Clinique de la Sauvegarde Lyon Cedex 09
France Centre Hospitalier de Montauban Montauban
France Clinique du Pont de Chaume 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 Nimes
France Centre Hospitalier Orleans-Hopital La Source Orleans
France Cabinet Medical Paris
France Centre Hospitalier Pitie Salpetriere Paris
France Hopital Bichat Claude Bernard Paris
France Hopital Cochin Paris
France Centre Hospitalier de Perigueux Perigueux
France Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie Pierre Benite Cedex
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 Lo
France Hopital Inter-armees Begin Saint Mande
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 Cabinet Medical Toulouse
France Clinique Medipole Garonne Toulouse
France Hopital Purpan 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

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Evaluation of the possible existence of fibromyalgia Fibromyalgia evaluated by the FiRST questionnaire Baseline, month 1, 3, 6, 12, 18 and 24
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change from baseline in fatigue over time Fatigue scored by the FACIT-Fatigue questionnaire Baseline, Month 1, 3, 6, 12, 18 and 24
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