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

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.

Exclusion Criteria

Patients unwilling/unable to fill in printed patient questionnaires.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CUDOS Score: Baseline (Visit 1) and 12 Months (Visit 3)	Baseline (Visit 1), 12 Months (Visit 3)	The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.

Secondary Outcome Measures

Name	Time	Method
CUDOS Score: Baseline (Visit 1) and 6 Months (Visit 2)	Baseline (Visit 1), 6 Months (Visit 2)	The CUDOS questionnaire assessed the level of depression in the past week. It consisted of 18 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUDOS score ranged from 0 to 72, higher score indicated more severe depression. Absolute values of CUDOS score at baseline (Visit 1) and 6 Months (Visit 2) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
CUXOS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	The clinically useful anxiety outcome scale (CUXOS) questionnaire assessed the level of anxiety in the past week. It consisted of 20 questions. For each question the participant indicated how well it described his/her feelings during past week on the following scale: 0 = not at all true, 1 = rarely true, 2 = sometimes true, 3 = often true and 4 = almost always true. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible CUXOS score ranged from 0 to 80, higher score indicated higher anxiety level. Absolute values of CUXOS score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
JSEQ Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	The Jenkins sleep evaluation questionnaire (JSEQ) questionnaire assessed the level of insomnia, sleep disturbance in the past month. It consisted of 4 questions related to 1) trouble falling asleep, 2) trouble staying asleep, 3) waking up several times per night, and 4) waking up feeling tired and worn out after a usual amount of sleep. The response alternatives were: 0 = not at all, 1 = 1-3 days, 2 = 4-7 days, 3 = 8-14 days, 4 = 15-21 days, and 5 = 22-30 days. The result of this questionnaire was the sum of responses to all questions and therefore the overall possible JSEQ score ranged from 0 to 20, higher score indicated lower sleep quality. Absolute values of JSEQ score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
VAS Score: Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Participants assessed how much arthritis impacted their life using a 100 millimeter (mm) visual analogue score (VAS) by placing a mark on the scale between 0 (not affecting) and 100 (maximal impact), which corresponded to the level arthritis affected their life. The score ranged from 0 mm to 100 mm, higher score indicated higher impact of arthritis on participants life. Absolute values of VAS score at baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3) are reported in descriptive data below. Mean relative change was calculated by averaging the relative changes of each of the participants (sum of all relative changes divided by the number of participants) and was reported in the statistical section.
Number of Participants Who Took at Least 1 Concomitant Treatment of Mental Illness Per Study Visit	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Number of participants who took at least 1 concomitant treatment like antidepressants, anxiolytics and hypnotics were reported in this outcome measure. Participants could have been counted in more than one category.
Number of Participants With Change in Dosage of Concomitant Medication Between 12 Months (Visit 3) and Baseline (Visit 1)	Baseline (Visit 1), 12 Months (Visit 3)	Number of participants with change in number of used medications and in their dosage between 12 Months (Visit 3) and Baseline (Visit 1) were reported in this outcome measure.
Absolute Change From Baseline in DAS28-4 (CRP) at 6 Months (Visit 2) and 12 Months (Visit 3)	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Disease activity score 28-4 (DAS28-4) C-reactive protein (CRP) was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (milligram per liter \[mg/L\]) and patient global assessment (PGA); participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\sqrt (TJC28) + 0.28\sqrt (SJC28) + 0.36\In (CRP in mg/1 + 1) + 0.014\PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) lower than (\<) 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and greater than (\>) 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
Number of Participants Achieving Remission as Assessed by DAS28-4 (CRP) < 2.6	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Remission was defined as DAS28-4 (CRP) \< 2.6. DAS28-4 CRP was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (mg/L) and PGA; participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\sqrt (TJC28) + 0.28\sqrt (SJC28) + 0.36\In (CRP in mg/1 + 1) + 0.014\PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) \< 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and \> 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
Number of Participants Achieving LDA as Assessed by DAS28-4 (CRP) < 3.2	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	Low disease activity (LDA) was defined as DAS28-4 (CRP) \< 3.2. DAS28-4 CRP was calculated from 28-tender joint counts and 28-swollen joint counts, CRP (mg/L) and PGA; participant assessed overall disease activity on VAS, score: 0 \[no arthritis\] to 100 \[extreme arthritis\]. DAS 28 -4 CRP = 0.56\sqrt (TJC28) + 0.28\sqrt (SJC28) + 0.36\In (CRP in mg/1 + 1) + 0.014\PtGA + 0.96; ln = natural logarithm, sqrt = square root of, mg = milligram, PtGA = patient's global assessment of health. DAS28-4 (CRP) \< 2.6 = RA in remission, 2.6 to 3.2 = low level of disease activity, 3.2 to 5.1 = active disease, may require change of treatment and \> 5.1 = very active disease, required careful monitoring and change of treatment. Total score range: 0 to 9.4, higher score indicated more disease activity.
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)	Baseline (Visit 1), 6 Months (Visit 2) and 12 Months (Visit 3)	EQ-5D-3L designed to assess impact on health-related quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain had 3 responses and scored from 1-3 (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems, where higher score indicated more severe problems. The EQ-5D-3L index score summarized each possible health state on a numerical scale ranging from -0.594 to 1. A score of 1 indicated full health, score of 0 indicated a state equivalent to being dead, and score lower than 0 indicated a state equivalent to the worst possible health status. Higher score indicated a better quality of life.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From start of study treatment to 12 months post treatment initiation	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and all non-SAEs. TEAEs were defined as newly occurring (not present at baseline) or worsening after first dose of study treatment.

Trial Locations

Locations (6): Thomayerova nemocnice
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Prague, Czech Republic, Czechia
Rheuma s.r.o.
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Breclav, Czechia
Revmatologie s.r.o.
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Brno, Czechia
Artroscan, s.r.o.
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Ostrava - Trebovice, Czechia
Revmatologicky ustav
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Praha 2, Czechia
Revmatologicke centrum s.r.o.
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Velke Bilovice, Czechia