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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992781
• Other study ID #: A3921330
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: February 7, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 7, 2024
• Est. primary completion date: February 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Czechia	Rheuma s.r.o.	Breclav
Czechia	Revmatologie s.r.o.	Brno
Czechia	Mangala Hospital & Mangala Kidney Foundation	Karlovy Vary
Czechia	Artroscan, s.r.o.	Ostrava - Trebovice
Czechia	Thomayerova nemocnice	Prague	Czech Republic
Czechia	Revmatologicky ustav	Praha 2
Czechia	Revmatologicka ambulance	Sumperk
Czechia	Revmatologicke centrum s.r.o.	Velke Bilovice

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Self Assessment of Clinically Useful Depression Outcome Scale (CUDOS)		Baseline, Visit 3 (12 months after start of Tofacitinib treatment)
Secondary	Baseline value and relative change between visit 2 and baseline of CUDOS score		Baseline, Visit 2 (6 months after start of Tofacitinib treatment)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Absolute change of DAS28 4 (Erythrocyte sedimentation rate (ESR))		Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment)
Secondary	Absolute change of DAS28 4 (C reactive protein (CRP))		Baseline, Visit 2, Visit 3 (6 months and 12 months after start of Tofacitinib treatment)

External Links

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