TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 421
- Locations
- 23
- Primary Endpoint
- Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Reading and writing with enough proficiency to complete assessment instruments in Korean
Exclusion Criteria
- •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.
Arms & Interventions
adalimumab users
patients who have been using adalimumab for 6 months or more and less than 2 year in RA patients
Intervention: adalimumab users
tofacitinib citrate users
patients who have been using tofacitinib citrate for 6 months or more and less than 2 year in RA patients
Intervention: tofacitinib citrate users
Outcomes
Primary Outcomes
Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
Time Frame: 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 Outcomes
- European Quality of Life-Visual Analogue Scale (EQ-VAS) Score(Day 1 (during approximately 20 months of data collection and observation))
- European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score(Day 1 (during approximately 20 months of data collection and observation))