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Trial record 1 of 1 for:    NCT03703817
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Rheumatoid Arthritis Satisfaction Outcome Research

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ClinicalTrials.gov Identifier: NCT03703817
Recruitment Status : Completed
First Posted : October 12, 2018
Results First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
Biostatistics, Preventive Medicinte Department, College of Medicine, Yonsei University
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 22, 2018
First Posted Date October 12, 2018
Results First Submitted Date February 22, 2021
Results First Posted Date March 16, 2021
Last Update Posted Date March 16, 2021
Actual Study Start Date July 2, 2018
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2021)
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.
Original Primary Outcome Measures
 (submitted: October 10, 2018)
Treatment Satisfaction Questionnaire for Medication for treatment satisfaction [ Time Frame: Baseline ]
Participant's response to treatment satisfaction will be collected using Treatment Satisfaction Questionnaire for Medication version 1.4. TSQM has 4 domains of Effectiveness, Convenience, Global satisfaction and Side effects. And there are 14 questions in total. The range of scores by each domain is from 0 to 100 where higher scores indicate great treatment satisfaction.
Change History
Current Secondary Outcome Measures
 (submitted: February 22, 2021)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: October 10, 2018)
  • EuroQoL-5 dimension-3 level index for Quality of life [ Time Frame: Baseline ]
    Participant's response to Quality of Life will be collected using EuroQoL-5 dimension-3 level index. EQ-5D-3L has 5 questions that thdy are asked to check on 3 point scale as 'no problems', 'some problems' and 'extreme problems'. Using scores of questions, the EQ-5D score will be calculated Through a fomula. The range of score is from -0.229 to 1.00 where higher scores indicate good quality of life.
  • EuroQoL Visual Analogue Scale for health status [ Time Frame: Baseline ]
    The EQ VAS requires patients to mark their health status on a visual analog scale. Patients will mark VAS of both current status and death. The range of scores by each domain is from 0 to 100 where higher scores indicate good status. Using VAS scores, the EQ-VAS score will be calculated Through a fomula. The range of score is from -1 to 1 where higher scores indicate good quality of life.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rheumatoid Arthritis Satisfaction Outcome Research
Official Title TREATMENT SATISFACTION COMPARISON IN RHEUMATOID ARTHRITIS PATIENTS BETWEEN TOFACITINIB CITRATE AND ADALIMUMAB, EACH USED IN RHEUMATOID ARTHRITIS TREATMENT
Brief 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.
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
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2021)
421
Original Estimated Enrollment
 (submitted: October 10, 2018)
840
Actual Study Completion Date March 12, 2020
Actual Primary Completion Date March 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03703817
Other Study ID Numbers A3921304
RA SATISFACTION ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Biostatistics, Preventive Medicinte Department, College of Medicine, Yonsei University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021