Rheumatoid Arthritis Satisfaction Outcome Research

Rheumatoid Arthritis Clinical Trial

Official title:

TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703817
• Other study ID #: A3921304
• Secondary ID: RA SATISFACTION
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine	Anyang
Korea, Republic of	Inje University Busan Paik Hospital, Department of Internal Medicine	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Daegu Catholic University Medical Center, Department of Rheumatology	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Eulji University Hospital	Daejeon	Republic OF Korea
Korea, Republic of	Wonkwang University Hospital / Division of Rheumatology	Iksan	Jeonlabuk-do
Korea, Republic of	Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju	Jeollabuk-do
Korea, Republic of	Dong-A University Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Catholic University of Korea, Kangnam St. Mary's Hospital	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Hanyang University Hospital, Department of Rheumatology	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	Kyung Hee University Hospital at Gangdong / Rheumatology	Seoul	Gangdong-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul
Korea, Republic of	Ajou University Hospital, Department of Rheumatology	Suwon-si	Kyeongki-do

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Biostatistics, Preventive Medicinte Department, College of Medicine, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1 (during approximately 20 months of data collection and observation)
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.	Day 1 (during approximately 20 months of data collection and observation)
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.	Day 1 (during approximately 20 months of data collection and observation)

External Links

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