Changes of Depression After First-year of Tofacitinib in RA Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-23

Study Completion Date

2024-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Newly prescribed tofacitinib

patients who were newly prescribed tofacitinib at baseline and who scored at least 11 points on CUDOS scale

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.