Rheumatoid Arthritis Satisfaction Outcome Research

NCT ID: NCT03703817

Last Updated: 2021-03-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

421 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2020-03-12

Brief Summary

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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

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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

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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tofacitinib citrate users

patients who have been using tofacitinib citrate for 6 months or more and less than 2 year in RA patients

No interventions assigned to this group

adalimumab users

patients who have been using adalimumab for 6 months or more and less than 2 year in RA patients

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Kyung Hee University Hospital at Gangdong / Rheumatology

Seoul, Gangdong-gu, South Korea

Site Status

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Wonkwang University Hospital / Division of Rheumatology

Iksan, Jeonlabuk-do, South Korea

Site Status

Ajou University Hospital, Department of Rheumatology

Suwon, Kyeongki-do, South Korea

Site Status

Eulji University Hospital

Daejeon, Republic of Korea, South Korea

Site Status

Asan Medical Center

Songpa-gu, Seoul, South Korea

Site Status

Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine

Anyang, , South Korea

Site Status

Inje University Busan Paik Hospital, Department of Internal Medicine

Busan, , South Korea

Site Status

Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status

Daegu Catholic University Medical Center, Department of Rheumatology

Daegu, , South Korea

Site Status

Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine

Incheon, , South Korea

Site Status

Pusan National University Hospital

Pusan, , South Korea

Site Status

Dong-A University Hospital

Pusan, , South Korea

Site Status

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Yonsei University Severance Hospital

Seoul, , South Korea

Site Status

Kyung Hee University Hospital

Seoul, , South Korea

Site Status

Hanyang University Hospital, Department of Rheumatology

Seoul, , South Korea

Site Status

Catholic University of Korea, Kangnam St. Mary's Hospital

Seoul, , South Korea

Site Status

Konkuk University Hospital, Department of Rheumatology

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim SK, Lee SH, Sun J, Lee SH, Jeon JY, Yoo HJ, Choe JY. Comparisons of treatment satisfaction and health-related quality of life in patients with rheumatoid arthritis treated with tofacitinib and adalimumab. Arthritis Res Ther. 2023 Apr 27;25(1):68. doi: 10.1186/s13075-023-03047-1.

Reference Type DERIVED
PMID: 37106411 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921304

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Other Identifiers

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RA SATISFACTION

Identifier Type: OTHER

Identifier Source: secondary_id

A3921304

Identifier Type: -

Identifier Source: org_study_id

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