Clinical trial NCT03703817: Rheumatoid Arthritis Satisfaction Outcome Research
Official title: TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Yonsei University
First posted: 2018-10-12
Enrollment: 421
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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

Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 years or older
2. Patients diagnosed with RA
3. Treatment groups:

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:

1. Patients currently on tofacitinib citrate or adalimumab for 2 year or more
2. Patients taking Azathioprine and cyclosporine
3. Patients participating in other drug interventional study
4. Patients who have been treated with bDMARDs except Rheumatoid arthritis.

Primary outcomes:
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4
timeFrame: Day 1 (during approximately 20 months of data collection and observation)
Secondary outcomes:
measure: European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score
timeFrame: Day 1 (during approximately 20 months of data collection and observation)
measure: European Quality of Life-Visual Analogue Scale (EQ-VAS) Score
timeFrame: Day 1 (during approximately 20 months of data collection and observation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong / Rheumatology
state: Gangdong-gu
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital / Division of Rheumatology
state: Jeonlabuk-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital, Department of Rheumatology
state: Kyeongki-do
city: Daejeon
country: Korea, Republic of
facility: Eulji University Hospital
state: Republic OF Korea
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital, Department of Internal Medicine
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center, Department of Rheumatology
city: Incheon
country: Korea, Republic of
facility: Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital, Department of Rheumatology
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea, Kangnam St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital, Department of Rheumatology
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: