Rheumatoid Arthritis Satisfaction Outcome Research
TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT
2 other identifiers
observational
421
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2020
CompletedResults Posted
Study results publicly available
March 16, 2021
CompletedMarch 16, 2021
February 1, 2021
1.7 years
June 22, 2018
February 22, 2021
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Secondary Outcomes (2)
European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score
Day 1 (during approximately 20 months of data collection and observation)
European Quality of Life-Visual Analogue Scale (EQ-VAS) Score
Day 1 (during approximately 20 months of data collection and observation)
Study Arms (2)
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
Eligibility Criteria
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
You may qualify if:
- Patients aged 19 years or older
- Patients diagnosed with RA
- Treatment groups:
- \) 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
You may not qualify if:
- Patients currently on tofacitinib citrate or adalimumab for 2 year or more
- Patients taking Azathioprine and cyclosporine
- Patients participating in other drug interventional study
- Patients who have been treated with bDMARDs except Rheumatoid arthritis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Yonsei Universitycollaborator
Study Sites (23)
Kyung Hee University Hospital at Gangdong / Rheumatology
Seoul, Gangdong-gu, 05278, South Korea
Chonbuk National University Hospital
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
Related Publications (1)
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.
PMID: 37106411DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2018
First Posted
October 12, 2018
Study Start
July 2, 2018
Primary Completion
March 12, 2020
Study Completion
March 12, 2020
Last Updated
March 16, 2021
Results First Posted
March 16, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share
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.