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Completed

NCT Number: NCT03703817

Rheumatoid Arthritis Satisfaction Outcome Research

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyung Hee University Hospital at Gangdong / Rheumatology, Seoul, Gangdong-gu, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 19 years or older
  • Patients diagnosed with RA
  • Treatment groups:
  • 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

  • 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.

Treatment and study plan

Primary outcomes

  1. Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4

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

    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.

Secondary outcomes

  1. European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Index Score

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

    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.

  2. European Quality of Life-Visual Analogue Scale (EQ-VAS) Score

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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Yonsei University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 12, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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