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Rheumatoid Arthritis Satisfaction Outcome Research

TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03703817
Enrollment
421
Registered
2018-10-12
Start date
2018-07-02
Completion date
2020-03-12
Last updated
2021-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis.

Detailed description

RA satisfaction OR: This study aim to compare treatment satisfaction and quality of life between patients who have been using tofacitinib citrate and patients who have been using adalimumab for 6 months or more and less than 2 year in RA treatment of rheumatoid arthritis. Study design: Non-interventional, multi-centers, cross-sectional study

Interventions

None listed

Sponsors

Yonsei University
CollaboratorOTHER
Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients aged 19 years or older 2. Patients diagnosed with RA 3. Treatment groups: 1\) Tofacitinib citrate users: Patients currently on treatment with tofacitinib citrate in RA therapy for 6 months or more 2) Adalimumab users: Patients currently on treatment with adalimumab in the RA therapy for 6 months or more 4. Reading and writing with enough proficiency to complete assessment instruments in Korean

Exclusion criteria

1. Patients currently on tofacitinib citrate or adalimumab for 2 year or more 2. Patients taking Azathioprine and cyclosporine 3. Patients participating in other drug interventional study 4. Patients who have been treated with bDMARDs except Rheumatoid arthritis.

Design outcomes

Primary

MeasureTime frameDescription
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Day 1 (during approximately 20 months of data collection and observation)TSQM version 1.4: participant rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score=greater satisfaction.

Secondary

MeasureTime frameDescription
European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index ScoreDay 1 (during approximately 20 months of data collection and observation)EQ-5D-3L assess health-related quality of life. It has 5 dimensions: mobility (M), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). Each dimension has 3 levels. For mobility, self-care and usual activities: 1= no effects, 2= sometimes affected, 3= very affected. For pain/discomfort and anxiety/depression: 1= none, 2= sometimes, 3= often. EQ-5D-3L index was calculated using formula = 1 - (0.0081 + \[0.1140 \* M2 + 0.6274 \* M3 + 0.0572 \* SC2 + 0.2073 \* SC3 + 0.0615 \* UA2 + 0.2812 \* UA3 + 0.0581 \* PD2+ 0.2353 \* PD3 + 0.0675 \* AD2 + 0.2351 \* AD3\]). In this formula, abbreviated form for dimension is followed by level, for example M2 = mobility level 2. Values were set to 1 if level was 2 or 3 for M2, SC2, UA2, PD2, AD2 or M3, SC3, UA3, PD3, AD3 respectively, else set to 0. Total score ranged from -0.27 to 1. Higher scores indicate better health.
European Quality of Life-Visual Analogue Scale (EQ-VAS) ScoreDay 1 (during approximately 20 months of data collection and observation)EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical, VAS on a scale ranging from and 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicated better health state.

Countries

South Korea

Participant flow

Pre-assignment details

In this study data was collected from participants who had been using tofacitinib citrate or adalimumab for 6 months or more and less than 2 years for rheumatoid arthritis (RA) treatment. Data was collected and analyzed from 2-July-2018 to 12-March-2020 (approximately 20 months), for comparing treatment satisfaction and quality of life between the 2 treatment groups.

Participants by arm

ArmCount
Tofacitinib Citrate
Participants who had been using tofacitinib citrate for more than 6 months or more and less than 2 years for RA treatment were included in the group.
281
Adalimumab
Participants who had been using adalimumab for more than 6 months or more and less than 2 years for RA treatment were included in the group.
129
Total410

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyNot meeting eligibility criteria74

Baseline characteristics

CharacteristicTofacitinib CitrateAdalimumabTotal
Age, Continuous54.473 years
STANDARD_DEVIATION 12.098
51.450 years
STANDARD_DEVIATION 12.176
53.522 years
STANDARD_DEVIATION 12.189
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
241 Participants115 Participants356 Participants
Sex: Female, Male
Male
40 Participants14 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2810 / 129
other
Total, other adverse events
2 / 2810 / 129
serious
Total, serious adverse events
0 / 2810 / 129

Outcome results

Primary

Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4

TSQM version 1.4: participant rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score=greater satisfaction.

Time frame: Day 1 (during approximately 20 months of data collection and observation)

Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.

ArmMeasureGroupValue (MEAN)Dispersion
Tofacitinib CitrateTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Effectiveness62.271 units on a scaleStandard Deviation 13.301
Tofacitinib CitrateTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Side effects93.390 units on a scaleStandard Deviation 16.668
Tofacitinib CitrateTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Convenience68.785 units on a scaleStandard Deviation 13.349
Tofacitinib CitrateTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Global satisfaction56.680 units on a scaleStandard Deviation 15.412
AdalimumabTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Global satisfaction59.860 units on a scaleStandard Deviation 15.558
AdalimumabTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Effectiveness64.191 units on a scaleStandard Deviation 13.315
AdalimumabTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Convenience64.946 units on a scaleStandard Deviation 12.845
AdalimumabTreatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4Side effects96.603 units on a scaleStandard Deviation 11.625
p-value: 0.3648Linear mixed model
p-value: 0.1395Conditional logistic regression
p-value: 0.0349Linear mixed model
p-value: 0.1546Linear mixed model
Secondary

European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score

EQ-5D-3L assess health-related quality of life. It has 5 dimensions: mobility (M), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). Each dimension has 3 levels. For mobility, self-care and usual activities: 1= no effects, 2= sometimes affected, 3= very affected. For pain/discomfort and anxiety/depression: 1= none, 2= sometimes, 3= often. EQ-5D-3L index was calculated using formula = 1 - (0.0081 + \[0.1140 \* M2 + 0.6274 \* M3 + 0.0572 \* SC2 + 0.2073 \* SC3 + 0.0615 \* UA2 + 0.2812 \* UA3 + 0.0581 \* PD2+ 0.2353 \* PD3 + 0.0675 \* AD2 + 0.2351 \* AD3\]). In this formula, abbreviated form for dimension is followed by level, for example M2 = mobility level 2. Values were set to 1 if level was 2 or 3 for M2, SC2, UA2, PD2, AD2 or M3, SC3, UA3, PD3, AD3 respectively, else set to 0. Total score ranged from -0.27 to 1. Higher scores indicate better health.

Time frame: Day 1 (during approximately 20 months of data collection and observation)

Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.

ArmMeasureValue (MEAN)Dispersion
Tofacitinib CitrateEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score0.812 units on a scaleStandard Deviation 0.146
AdalimumabEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score0.808 units on a scaleStandard Deviation 0.134
p-value: 0.1602Conditional logistic regression model
Secondary

European Quality of Life-Visual Analogue Scale (EQ-VAS) Score

EQ-VAS is a standardized tool for measuring overall health. EQ-VAS recorded the participant's self-rated health on a vertical, VAS on a scale ranging from and 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores indicated better health state.

Time frame: Day 1 (during approximately 20 months of data collection and observation)

Population: The propensity score method (greedy matching method) was used in analysis of the outcome measure. The purpose of the propensity score was to create conditions similar to those of randomized trials by balancing the covariates in participants between the groups. It reduces multidimensional covariates into a one-dimensional score. Here, 'Overall Number of Participants Analyzed' signifies number of participant evaluable for this outcome measure derived from propensity score method.

ArmMeasureValue (MEAN)Dispersion
Tofacitinib CitrateEuropean Quality of Life-Visual Analogue Scale (EQ-VAS) Score65.403 units on a scaleStandard Deviation 19.974
AdalimumabEuropean Quality of Life-Visual Analogue Scale (EQ-VAS) Score65.668 units on a scaleStandard Deviation 19.554
p-value: 0.9921Linear mixed model

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026