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SELECT AXIS RW: Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05609643
Collaborator
(none)
100
Enrollment
23
Locations
41.9
Anticipated Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis [AS]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA.

Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan.

Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Study to Evaluate Safety and Effectiveness of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan (SELECT AXIS RW)
    Actual Study Start Date :
    Jul 6, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Rinvoq

    Participants will receive Rinvoq as prescribed by their physician according to local label.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR) [Up to 52 Weeks]

      Incidence of serious drug related adverse reactions will be assessed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS.

    • Participant who is administered the first dose of Rinvoq for AS.

    Exclusion Criteria:

    • Participant with prior treatment by JAK inhibitors.

    • Participant currently participating in another clinical study except non-interventional study.

    • Participant for whom upadacitinib is contraindicated.

    • Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kurotsuchi Orthopaedic Clinic /ID# 251076 Kasugashi Aichi Japan 8160849
    2 Tomita Clinic /ID# 251075 Kashiwa-shi Chiba Japan 277-0005
    3 Yagi Hospital /ID# 251078 Fukuoka-shi Fukuoka Japan 812-0054
    4 Kunou Orthopedic Clinic /ID# 252168 Kitakyushu-shi Fukuoka Japan 800-0206
    5 Hospital of the University of Occupational and Environmental Health, Japan /ID# 252570 Kitakyushu-shi Fukuoka Japan 807-8556
    6 Katayama Orthopedic Rheumatology Clinic /ID# 251071 Asahikawa-shi Hokkaido Japan 078-8243
    7 Kobe Kaisei Hospital /ID# 251073 Kobe-shi Hyogo Japan 657-0068
    8 Hyogo Medical University Hospital /ID# 253200 Nishinomiya-shi Hyogo Japan 663-8501
    9 Kanazawa University Hospital /ID# 252170 Kanazawa-shi Ishikawa Japan 920-8641
    10 Sanuki Municipal Hospital /ID# 251104 Sanuki-shi Kagawa Japan 769-2393
    11 Yokohama Minami Kyousai Hosp /ID# 252172 Yokohama-shi Kanagawa Japan 236-0037
    12 Chiyoda Hospital /ID# 251077 Hyuga-shi Miyazaki Japan 883-0064
    13 Sasebo Chuo Hospital /ID# 253202 Sasebo-shi Nagasaki Japan 857-1195
    14 Oribe Clinic of Rheumatism and Medicine /ID# 251079 Oita-shi Oita Japan 870-0823
    15 National Hospital Organization Osaka Minami Medical Center /ID# 251072 Kawachinagano Shi Osaka Japan 586-8521
    16 Kinshukai Infusion Clinic /ID# 251070 Osaka-shi Osaka Japan 530-0011
    17 Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166 Osaka-shi Osaka Japan 550-0006
    18 Koga Community Hospital /ID# 251074 Yaizu City Shizuoka Japan 425-0088
    19 Juntendo University Hospital /ID# 251103 Bunkyo-ku Tokyo Japan 113-8431
    20 Tokyo Medical And Dental University Hospital /ID# 252569 Bunkyo-ku Tokyo Japan 113-8519
    21 Takaoka Rheumatic Orthopedic Clinic /ID# 252895 Takaoka-shi Toyama Japan 933-0874
    22 Toyama University Hospital /ID# 251682 Toyama-shi Toyama Japan 930-0194
    23 Kasugai Clinic /ID# 253201 Fuefuki-shi Yamanashi Japan 4060002

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05609643
    Other Study ID Numbers:
    • P22-963
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Ankylosing Spondylitis
    RINVOQ
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Spondylitis, Ankylosing

    Study Results

    No Results Posted as of Jan 26, 2023