Changes of Depression After First-year of Tofacitinib in RA Patients
NCT03992781
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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).
- Capable of understanding and signing a written informed consent form.
- 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.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Patients unwilling/unable to fill in printed patient questionnaires.
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Advanced Information
| 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 | Newly prescribed tofacitinib
patients who were newly prescribed tofacitinib at baseline and who scored at least 11 points on CUDOS scale | ||||
| 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 | January 22, 2024 | ||||
| Estimated Primary Completion Date | January 22, 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | July 2021 | ||||