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

Study Overview
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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.

Official Title
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NON-INTERVENTIONAL STUDY TO REVIEW THE CHANGES OF DEPRESSION AFTER FIRST-YEAR OF TOFACITINIB TREATMENT IN RHEUMATOID ARTHRITIS (XELJANZ (Registered))

Conditions
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Rheumatoid Arthritis

Participation Criteria
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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. Exclusion Criteria: Patients unwilling/unable to fill in printed patient questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly prescribed tofacitinib<br>patients who were newly prescribed tofacitinib at baseline and who scored at least 11 points on CUDOS scale | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Self Assessment of Clinically Useful Depression Outcome Scale (CUDOS) |  | Baseline, Visit 3 (12 months after start of Tofacitinib treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline value and relative change between visit 2 and baseline of CUDOS score |  | Baseline, Visit 2 (6 months after start of Tofacitinib treatment) | 
| Changes in Clinically Useful Anxiety Outcome Scale (CUXOS) for evaluation of anxiety |  | Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) | 
| Changes in Jenkins Sleep Evaluation Questionnaire (JSEQ) for evaluation of insomnia |  | Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) | 
| Changes in Visual Analog Scale (VAS) score for evaluation of arthritis pain |  | Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) | 
| Counts of concomitant medication (antidepressants, analgesics, anxiolytics and hypnotics) together with doses for each and the change in number of used medicaments and in their dosage |  | Baseline, Visit 3 (12 months after start of Tofacitinib treatment) | 
| Absolute change of DAS28 4 (Erythrocyte sedimentation rate (ESR)) |  | Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) | 
| Absolute change of DAS28 4 (C reactive protein (CRP)) |  | Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment) |