IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
- Sponsor
- Pfizer
- Study ID
- NCT03981900
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tofacitinib — DRUG5 mg BID, oral administrtaion
- Tofacitinib — DRUGtablet form 11mg once daily oral
Study Details
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.
Key Dates
- Start date
- Jan 4, 2019
- Status verified
- Jun 2024
- Primary completion
- Feb 6, 2023
- Completion
- Feb 6, 2023
Study Design
- Enrollment
- 314 participants (actual)
Arms
- Arm: Rheumatoid arthritisAll participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib
Primary Outcome Measure
Duration of Tofacitinib Drug Survival [ Time Frame: 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) ]
Related Studies
- Laser-based Photoacoustic Tomography of Human Inflammatory ArthritisRecruiting · University of Michigan · Ann Arbor, Michigan
- IMPACT - AndHealth Autoimmune Research RegistryRecruiting · AndHealth · Columbus, Ohio
- R-2487 in Patients With Rheumatoid ArthritisPHASE1 · Recruiting · Rise Therapeutics LLC · San Diego, California
- Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid ArthritisNot Yet Recruiting · Tufts Medical Center · Boston, Massachusetts