AzTrials
AzTrials

Rheumatoid ArthritisNCT03703817

Rheumatoid Arthritis Satisfaction Outcome Research

An observational study of Rheumatoid Arthritis, run by Pfizer at 23 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
421 participants
Where
23 sitesSouth Korea
Study dates
2 Jul 2018to 12 Mar 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Patients aged 19 years or older
  • Patients diagnosed with RA
  • 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

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

South Korea23 sites

  • Hallym University Sacred Heart Hospital/Rheumatology, Internal Medicine

    Anyang, 431-070

  • Inje University Busan Paik Hospital, Department of Internal Medicine

    Busan, 614-735

  • Kosin University Gospel Hospital

    Busan, 6

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

  • Daegu Catholic University Medical Center, Department of Rheumatology

    Daegu, 705-718

  • Eulji University Hospital

    Daejeon, Republic of Korea, 35233

  • Wonkwang University Hospital / Division of Rheumatology

    Iksan, Jeonlabuk-do, 570711

  • Gacheon Medical School Gil Medical Center, Rheumatology, Internal Medicine

    Incheon, 405-760

  • Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 561-712

  • Pusan National University Hospital

    Pusan, 602-739

  • Dong-A University Hospital

    Pusan

  • Kyung Hee University Hospital at Gangdong / Rheumatology

    Seoul, Gangdong-gu, 05278

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University Severance Hospital

    Seoul, 120-752

  • Kyung Hee University Hospital

    Seoul, 130-702

  • Hanyang University Hospital, Department of Rheumatology

    Seoul, 133-792

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

    Seoul, 137-701

  • Konkuk University Hospital, Department of Rheumatology

    Seoul, 143-914

  • Chung-Ang University Hospital

    Seoul, 156-755

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-056

  • Asan Medical Center

    Songpa-gu, Seoul, 138-736

  • Ajou University Hospital, Department of Rheumatology

    Suwon, Kyeongki-do, 443-721

Other trials in South Korea

About this study

Official title: 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.

Read the 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

Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03703817
Study groupRoleWhat they receive
tofacitinib citrate userspatients who have been using tofacitinib citrate for 6 months or more and less than 2 year in RA patients
adalimumab userspatients who have been using adalimumab for 6 months or more and less than 2 year in RA patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 1 (during approximately 20 months of data collection and observation)

Secondary outcomes (2)

  1. 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.

    Measured: Day 1 (during approximately 20 months of data collection and observation)

  2. 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.

    Measured: Day 1 (during approximately 20 months of data collection and observation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2018
  2. Study start2 Jul 2018
  3. Primary completion12 Mar 2020
  4. Study completion12 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03703817
Sponsor's protocol ID
A3921304
Other IDs
RA SATISFACTION
Status last verified
Feb 2021
First submitted
22 Jun 2018
Last updated
16 Mar 2021
FDA-regulated drug
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 37106411

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer at 23 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 (time frame: Day 1 (during approximately 20 months of data collection and observation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03703817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

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