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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03981900
• Date of registration: 07/06/2019
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
• Scientific 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.
• Date of first enrolment: January 4, 2019
• Target sample size: 314
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03981900
• Study type: Observational

Countries of recruitment

France

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Tofacitinib

Primary Outcome(s)

Duration of Tofacitinib survival [Time Frame: 24 months]

Secondary Outcome(s)

Change from baseline in coping adaptative strategy adopted by the participant [Time Frame: Baseline, month 1, 3, 6, 12, 18 and 24]

Change from baseline in catastrophising behaviour adopted by the participant [Time Frame: Baseline, month 1, 3, 6, 12, 18 and 24]

Change from baseline in score DAS28 ESR/CRP and in its components over time [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Change from baseline in patient compliance over time (GIRERD Questionnaire) [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Change from baseline in the number of painful joints (TJC) over time [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Change from baseline in overall health status over time (EuroQoL EQ-5D-3L questionnaire) [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Change from baseline in the number of swollen joints (SJC) over time [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Evaluation of response to treatment considering outcome of the DAS28 (EULAR criteria) [Time Frame: Month 1, 3, 6, 12, 18 and 24]

Evaluation of the possible existence of fibromyalgia [Time Frame: Baseline, month 1, 3, 6, 12, 18 and 24]

Percentage of participants with low disease activity (LDA) [Time Frame: Month 1, 3, 6, 12, 18 and 24]

Change from baseline in fatigue over time [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Change from baseline in the duration of morning stiffness over time [Time Frame: Baseline, month 1, 3, 6, 12, 18 and 24]

Percentage of participants in remission [Time Frame: Month 1, 3, 6, 12, 18 and 24]

Change from baseline in quality of life over time [Time Frame: Baseline, Month 1, 3, 6, 12, 18 and 24]

Secondary ID(s)

A3921313

DeFacTo

Source(s) of Monetary Support

Please refer to primary and secondary sponsors