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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03992781
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Study Start: 2020-07-23
• Primary Completion: 2024-02-07
• Study Completion: 2024-02-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

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Exclusion Criteria

• Patients unwilling/unable to fill in printed patient questionnaires.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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 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)
Absolute change of DAS28 4 (Erythrocyte sedimentation rate (ESR))	Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment)
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 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)
Absolute change of DAS28 4 (C reactive protein (CRP))	Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment)

Trial Locations

Locations (8)

Revmatologicky ustav; 🇨🇿 Praha 2, Czechia

Revmatologicke centrum s.r.o.; 🇨🇿 Velke Bilovice, Czechia

Mangala Hospital & Mangala Kidney Foundation; 🇨🇿 Karlovy Vary, Czechia

Artroscan, s.r.o.; 🇨🇿 Ostrava - Trebovice, Czechia

Revmatologicka ambulance; 🇨🇿 Sumperk, Czechia

Rheuma s.r.o.; 🇨🇿 Breclav, Czechia

Thomayerova nemocnice; 🇨🇿 Prague, Czech Republic, Czechia

Revmatologie s.r.o.; 🇨🇿 Brno, Czechia