Rheumatoid Arthritis Satisfaction Outcome Research

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

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 Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 421

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of, 431-070
    • Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine
  • Busan, Korea, Republic of, 614-735
    • Inje University Busan Paik Hospital, Department of Internal Medicine
  • Busan, Korea, Republic of, 6
    • Kosin University Gospel Hospital
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of, 705-718
    • Daegu Catholic University Medical Center, Department of Rheumatology
  • Incheon, Korea, Republic of, 405-760
    • Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine
  • Pusan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Dong-A University Hospital
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 156-755
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 130-702
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 120-752
    • Yonsei University Severance Hospital
  • Seoul, Korea, Republic of, 133-792
    • Hanyang University Hospital, Department of Rheumatology
  • Seoul, Korea, Republic of, 137-701
    • Catholic University of Korea, kangnam St. Mary's Hospital
  • Seoul, Korea, Republic of, 143-914
    • Konkuk University Hospital, Department of Rheumatology
  • Seoul, Korea, Republic of, 158-056
    • Ewha Womans University Mokdong Hospital
  • Gangdong-gu
    • Seoul, Gangdong-gu, Korea, Republic of, 05278
      • Kyung Hee University Hospital at Gangdong / Rheumatology
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 561-712
      • Chonbuk National University Hospital
  • Jeonlabuk-do
    • Iksan, Jeonlabuk-do, Korea, Republic of, 570711
      • Wonkwang University Hospital / Division of Rheumatology
  • Kyeongki-do
    • Suwon-si, Kyeongki-do, Korea, Republic of, 443-721
      • Ajou University Hospital, Department of Rheumatology
  • Republic OF Korea
    • Daejeon, Republic OF Korea, Korea, Republic of, 35233
      • Eulji University Hospital
  • Seoul
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Biostatistics, Preventive Medicinte Department, College of Medicine, Yonsei University

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2018
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: A3921304; RA SATISFACTION (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No