IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis
NCT03981900
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Adult Trials: 18+ Years
- 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
- 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.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis | ||||
| 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. | ||||
| 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. | ||||
| Detailed 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 | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients with a diagnosis of moderate to severe active rheumatoid arthritis for whom the rheumatologist has decided to initiate a treatment with Tofacitinib | ||||
| Condition | Arthritis, Rheumatoid | ||||
| Intervention | Drug: Tofacitinib
5 mg BID, oral administrtaion Other Name: Xeljanz | ||||
| Study Groups/Cohorts | Rheumatoid arthritis
All participants with a diagnosis of moderate to severe active rheumatoid arthritis and treated with Tofacitinib Intervention: Drug: Tofacitinib | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 500 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 30, 2022 | ||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03981900 | ||||
| Other Study ID Numbers | A3921313 DeFacTo ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | October 2020 | ||||