Changes of Depression After First-year of Tofacitinib in RA Patients
NCT03992781
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Adult Trials: 18+ Years
- Patients aged ≥18 years.
- Moderate to severe activity of rheumatoid arthritis (DAS28 ≥3.2).
- Patient for whom the physician decision has been made to initiate a treatment with Tofacitinib.
- Patient with at least minimal level of depression (CUDOS questionnaire ≥11 points).
- Patient who have been prescribed Tofacitinib treatment according to SmPC and SUKL's criteria for reimbursement.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
- Contraindications according to Xeljanz® SmPC
- Receipt of any investigational drug within 3 months before study inclusion.
- 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 | Changes of Depression After First-year of Tofacitinib in RA Patients | ||||
| Official Title | NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered)) | ||||
| Brief Summary | 12-month, single arm, prospective, non-interventional, multi-center study according to Czech legal definitions (Law 378/2007 Sb.).The primary objective of this study is to describe and evaluate the changes of depression level within 12 months from the start of tofacitinib therapy in patients with RA and at least minimal level of depression. Primary goal is to find out if treatment by tofacitinib reduces the depression by at least 10% during 12 months. | ||||
| Detailed Description | Not Provided | ||||
| 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 rheumatoid arthritis who are initiated on tofacitinib as part of a usual care setting. | ||||
| Condition | Rheumatoid Arthritis | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| 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 | 154 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | May 31, 2023 | ||||
| Estimated Primary Completion Date | May 31, 2023 (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 | Czechia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03992781 | ||||
| Other Study ID Numbers | A3921330 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| 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 | ||||