Clinical trial NCT03992781: 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))
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who are initiated on tofacitinib as part of a usual care setting.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 12 Months (Visit 3)
Secondary outcomes:
measure: CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2)
measure: CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)
timeFrame: Baseline (Visit 1), 12 Months (Visit 3)
measure: Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Change From Baseline in EuroQol Five Dimension - 3 Level (EQ-5D-3L) Health State Profile at 6 Months (Visit 2) and 12 Months (Visit 3)
timeFrame: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study treatment to 12 months post treatment initiation
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Thomayerova nemocnice
state: Czech Republic
city: Breclav
country: Czechia
facility: Rheuma s.r.o.
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Ostrava - Trebovice
country: Czechia
facility: Artroscan, s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Velke Bilovice
country: Czechia
facility: Revmatologicke centrum s.r.o.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: