Trial Outcomes & Findings for Rheumatoid Arthritis Satisfaction Outcome Research (NCT NCT03703817)
NCT ID: NCT03703817
Last Updated: 2021-03-16
Results Overview
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.
COMPLETED
421 participants
Day 1 (during approximately 20 months of data collection and observation)
2021-03-16
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
133
|
|
Overall Study
COMPLETED
|
281
|
129
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Not meeting eligibility criteria
|
7
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Tofacitinib Citrate
n=281 Participants
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.
|
Adalimumab
n=129 Participants
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.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.473 years
STANDARD_DEVIATION 12.098 • n=281 Participants
|
51.450 years
STANDARD_DEVIATION 12.176 • n=129 Participants
|
53.522 years
STANDARD_DEVIATION 12.189 • n=410 Participants
|
|
Sex: Female, Male
Female
|
241 Participants
n=281 Participants
|
115 Participants
n=129 Participants
|
356 Participants
n=410 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=281 Participants
|
14 Participants
n=129 Participants
|
54 Participants
n=410 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib Citrate
n=139 Participants
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.
|
Adalimumab
n=92 Participants
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.
|
|---|---|---|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Effectiveness
|
62.271 units on a scale
Standard Deviation 13.301
|
64.191 units on a scale
Standard Deviation 13.315
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Side effects
|
93.390 units on a scale
Standard Deviation 16.668
|
96.603 units on a scale
Standard Deviation 11.625
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Convenience
|
68.785 units on a scale
Standard Deviation 13.349
|
64.946 units on a scale
Standard Deviation 12.845
|
|
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Global satisfaction
|
56.680 units on a scale
Standard Deviation 15.412
|
59.860 units on a scale
Standard Deviation 15.558
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib Citrate
n=139 Participants
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.
|
Adalimumab
n=92 Participants
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.
|
|---|---|---|
|
European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score
|
0.812 units on a scale
Standard Deviation 0.146
|
0.808 units on a scale
Standard Deviation 0.134
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Tofacitinib Citrate
n=139 Participants
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.
|
Adalimumab
n=92 Participants
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.
|
|---|---|---|
|
European Quality of Life-Visual Analogue Scale (EQ-VAS) Score
|
65.403 units on a scale
Standard Deviation 19.974
|
65.668 units on a scale
Standard Deviation 19.554
|
Adverse Events
Tofacitinib Citrate
Adalimumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tofacitinib Citrate
n=281 participants at risk
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.
|
Adalimumab
n=129 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Viral infection
|
0.36%
1/281 • Up to 28 days after the last administration of tofacitinib citrate or adalimumab (during approximately 20 months of data collection and observation)
Full analysis set included all participants who satisfied the inclusion criteria and were registered for the study.
|
0.00%
0/129 • Up to 28 days after the last administration of tofacitinib citrate or adalimumab (during approximately 20 months of data collection and observation)
Full analysis set included all participants who satisfied the inclusion criteria and were registered for the study.
|
|
Infections and infestations
Acute Sinusitis
|
0.36%
1/281 • Up to 28 days after the last administration of tofacitinib citrate or adalimumab (during approximately 20 months of data collection and observation)
Full analysis set included all participants who satisfied the inclusion criteria and were registered for the study.
|
0.00%
0/129 • Up to 28 days after the last administration of tofacitinib citrate or adalimumab (during approximately 20 months of data collection and observation)
Full analysis set included all participants who satisfied the inclusion criteria and were registered for the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER