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| ID | Type | Description | Link |
|---|---|---|---|
| RA SATISFACTION | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Yonsei University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tofacitinib citrate users | patients who have been using tofacitinib citrate for 6 months or more and less than 2 year in RA patients | ||
| adalimumab users | patients who have been using adalimumab for 6 months or more and less than 2 year in RA patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 (during approximately 20 months of data collection and observation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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The study population is RA patients who have been using tofacitinib citrate or adalimumab for 6 months or more and less than 2 year in RA treatment at participating institution
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital at Gangdong / Rheumatology | Seoul | Gangdong-gu | 05278 | South Korea | ||
| Chonbuk National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37106411 | Derived | Kim SK, Lee SH, Sun J, Lee SH, Jeon JY, Yoo HJ, Choe JY. Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab. Arthritis Res Ther. 2023 Apr 27;25(1):68. doi: 10.1186/s13075-023-03047-1. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Adalimumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2019 | Feb 22, 2021 |
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| Day 1 (during approximately 20 months of data collection and observation) |
| 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. | Day 1 (during approximately 20 months of data collection and observation) |
| Jeonju |
| Jeollabuk-do |
| 561-712 |
| South Korea |
| Wonkwang University Hospital / Division of Rheumatology | Iksan | Jeonlabuk-do | 570711 | South Korea |
| Ajou University Hospital, Department of Rheumatology | Suwon | Kyeongki-do | 443-721 | South Korea |
| Eulji University Hospital | Daejeon | Republic of Korea | 35233 | South Korea |
| Asan Medical Center | Songpa-gu | Seoul | 138-736 | South Korea |
| Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine | Anyang | 431-070 | South Korea |
| Inje University Busan Paik Hospital, Department of Internal Medicine | Busan | 614-735 | South Korea |
| Kosin University Gospel Hospital | Busan | 6 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 700-712 | South Korea |
| Daegu Catholic University Medical Center, Department of Rheumatology | Daegu | 705-718 | South Korea |
| Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine | Incheon | 405-760 | South Korea |
| Pusan National University Hospital | Pusan | 602-739 | South Korea |
| Dong-A University Hospital | Pusan | South Korea |
| Hanyang University Seoul Hospital | Seoul | 04763 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Kyung Hee University Hospital | Seoul | 130-702 | South Korea |
| Hanyang University Hospital, Department of Rheumatology | Seoul | 133-792 | South Korea |
| Catholic University of Korea, Kangnam St. Mary's Hospital | Seoul | 137-701 | South Korea |
| Konkuk University Hospital, Department of Rheumatology | Seoul | 143-914 | South Korea |
| Chung-Ang University Hospital | Seoul | 156-755 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 158-056 | South Korea |
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.
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set included all participants who satisfied the inclusion criteria and were registered for the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (during approximately 20 months of data collection and observation) |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (during approximately 20 months of data collection and observation) |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 (during approximately 20 months of data collection and observation) |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 281 | 0 | 281 | 2 | 281 |
| EG001 | 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. | 0 | 129 | 0 | 129 | 0 | 129 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral infection | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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| Acute Sinusitis | Infections and infestations | MedDRA Version 22.1 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Feb 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Convenience |
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| Global satisfaction |
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| 0.1395 |
| Superiority |
Side effect: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics). |
| Linear mixed model | 0.0349 | Superiority | Convenience: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics). |
| Linear mixed model | 0.1546 | Superiority | Global satisfaction: Multivariate analysis was used to control and remove the possible influence of the independent variables (demographic and clinical characteristics). |
| OG001 | 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. |
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