Study to Evaluate Safety and Effects of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs in People Treated for Rheumatoid Arthritis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05572567
Collaborator
(none)
1
1

Study Details

Study Description

Brief Summary

This is a secondary structured database observational study conducted in Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs, including tofacitinib, collected as part of the CorEvitas Japan RA Registry.

The data as of September 2022 will be used for this study. The study will include data from March 2016 to the latest data cut available in 2022 for both effectiveness and safety outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Observational Study Within the CorEvitas Registry to Evaluate Safety and Effectiveness of Tofacitinib and Biologic Disease Modifying Antirheumatic Drugs (bDMARDs) in Japan Among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis
    Actual Study Start Date :
    Oct 10, 2022
    Actual Primary Completion Date :
    Oct 10, 2022
    Actual Study Completion Date :
    Oct 10, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Rheumatoid Arthritis (RA) patients treated with biologic and nonbiologic DMARDs

    to include all Japanese patients taking Tofacitinib

    Outcome Measures

    Primary Outcome Measures

    1. Incidence rates of selected safety events of interest [Index date, 90 days after the end of therapy or end of data collection]

      Safety events of interest ie. total CVD, serious infections, total Herpes Zoster, and total malignancy excluding NMSC (non-melanoma skin cancer) in the Tofacitinib, non-TNF, anti-TNFi, and MTX cohorts by estimating marginal means of incidence rates of selected safety events of interest.

    Secondary Outcome Measures

    1. Mean change from baseline to 6-months of CDAI [Index date, 6-month follow-up visit]

      The Clinical Disease Activity Index(CDAI) is the sum of 4 outcome parameters: tender and swollen joint counts (28 joints assessed) and patient's and physician's global assessments of disease activity (on a 0-10-cm visual analog scale). Range of possible scores is 0-76.

    2. Mean change from baseline to 6-months of J-HAQ [Index date, 6-month follow-up visit]

      J-HAQ is Japanese version of the HAQ-DI. The Health Assessment Questionnaire-Disability Index (HAQ-DI) assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status

    3. Mean change from baseline to 6-months of patient pain VAS [Index date, 6-month follow-up visit]

      Patient pain VAS scale is measured on a visual analog scale ranging from 0 (no pain) to 100 mm (worst pain).

    4. Mean change from baseline to 6-months of patient global assessment VAS [Index date, 6-month follow-up visit]

      Patient global assessment VAS is measured on a visual analog scale ranging from 0 (no arthritis activity) to 100 mm (extremely active arthritis).

    5. Mean change from baseline to 6-months of patient fatigue VAS [Index date, 6-month follow-up visit]

      Patient fatigue VAS is measured on a visual analog scale ranging from 0 (no fatigue) to 100 mm (worst fatigue).

    6. Mean change from baseline to 6-months of morning stiffness [Index date, 6-month follow-up visit]

      Patient morning stiffness assesses the length of time of morning stiffness (in hours/minutes).

    7. Mean change from baseline to 6-months of EA-5D-5L [Index date, 6-month follow-up visit]

      The EQ 5D 5L is a validated health outcomes instrument that generates a simple descriptive profile on 5 domains of health. The domains are rated on 5 levels, and the instrument is composed of both a short, cognitively simple questionnaire and a VAS scale.

    8. Achievement of minimally clinically important difference (MCID) at 6-month follow-up [6-month follow-up visit]

      Achievement of minimally clinically important difference (MCID) [4] at 6-month follow-up, based on the CDAI value at initiation. Specifically, MCID > 1 if CDAI at baseline is ≤ 10, MCID > 6 if CDAI at baseline ranges between (10, 22], MCID > 12 if CDAI at baseline > 22.

    9. Modified ACR20/50/70 [6-month follow-up visit]

      Modified ACR20/50/70 (mACR20/50/70), defined as 20/50/70% improvement in tender and swollen joint count, and 20/50/70% improvement in 2 of the following four domains at the 6-month follow-up visit: patient pain assessment, patient global assessment, physician global assessment, patient self-addressed disability, measured by the J-HAQ score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosed with Rheumatoid Arthritis (RA) according to the 1987 American College of Rheumatology (ACR) or the ACR/European Lead Against Rheumatism (EULAR) 2010 RA Classification Criteria;

    • At least 18 years of age or older;

    • Was / Must be prescribed or switching to the following eligible medication for the first time ever at the enrollment visit:

    • csDMARD: methotrexate (closed in February 2018);

    • Anti-TNF bDMARD: adalimumab (originator or biosimilar), certolizumab pegol, etanercept (originator or biosimilar), golimumab, infliximab (originator or biosimilar), or any other anti-TNF biosimilar approved during the study;

    • Non-TNF bDMARD: abatacept, tocilizumab, sarilumab (closed in June 2020);

    • JAK inhibitor: tofacitinib, baricitinib, peficitinib, filgotinib, upadacitinib.

    Exclusion Criteria:
    • Data that are prior to March 2016 and after June 2022

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Tokyo Japan

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT05572567
    Other Study ID Numbers:
    • A3921429
    First Posted:
    Oct 7, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 1, 2022