Rheumatoid Arthritis Satisfaction Outcome Research
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT03703817
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 Day 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 Outcome Measures
Name Time Method European Quality of Life-Visual Analogue Scale (EQ-VAS) Score Day 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.
European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score Day 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.
Trial Locations
- Locations (23)
Kyung Hee University Hospital at Gangdong / Rheumatology
🇰🇷Seoul, Gangdong-gu, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Jeollabuk-do, Korea, Republic of
Wonkwang University Hospital / Division of Rheumatology
🇰🇷Iksan, Jeonlabuk-do, Korea, Republic of
Ajou University Hospital, Department of Rheumatology
🇰🇷Suwon-si, Kyeongki-do, Korea, Republic of
Eulji University Hospital
🇰🇷Daejeon, Republic OF Korea, Korea, Republic of
Asan Medical Center
🇰🇷Songpa-gu, Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
🇰🇷Anyang, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine
🇰🇷Incheon, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Inje University Busan Paik Hospital, Department of Internal Medicine
🇰🇷Busan, Korea, Republic of
Daegu Catholic University Medical Center, Department of Rheumatology
🇰🇷Daegu, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Dong-A University Hospital
🇰🇷Pusan, Korea, Republic of
Hanyang University Hospital, Department of Rheumatology
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital, Department of Rheumatology
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Catholic University of Korea, Kangnam St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of