Clinical trial NCT05609643: Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan
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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-11-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with Ankylosing Spondylitis (AS)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR)
timeFrame: Up to 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kasugashi
country: Japan
facility: Kurotsuchi Orthopaedic Clinic /ID# 251076
state: Aichi
city: Nagoya-shi
country: Japan
facility: Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 254435
state: Aichi
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 258204
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Tomita Clinic /ID# 251075
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Yamada Rheumatology Clinic /ID# 264182
state: Ehime
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 261974
state: Ehime
city: Noda-shi
country: Japan
facility: Noda Hospital /ID# 254429
state: Fukui
city: Toyama
country: Japan
facility: Toyama Hospital /ID# 268281
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Yagi Hospital /ID# 251078
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kunou Orthopedic Clinic /ID# 252168
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 252570
state: Fukuoka
city: Takasaki-shi
country: Japan
facility: Inoue Hospital /ID# 261959
state: Gunma
city: Asahikawa-shi
country: Japan
facility: Katayama Orthopedic Rheumatology Clinic /ID# 251071
state: Hokkaido
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 268282
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Rheumatology and immunology clinic /ID# 256175
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 258203
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Himeji Medical Center /ID# 255197
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe Kaisei Hospital /ID# 251073
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 253200
state: Hyogo
city: 水戸市
country: Japan
facility: Clinic Quest For Rheumatology & Well-being /ID# 268817
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 252170
state: Ishikawa
city: Sanuki-shi
country: Japan
facility: Sanuki Municipal Hospital /ID# 251104
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 256997
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Toranomon Hospital Kajigaya /ID# 260158
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Takahashi Clinic /ID# 252924
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 254480
state: Kanagawa
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 258149
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Sakuragicho Yokohama Clinic /ID# 266671
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Minami Kyousai Hosp /ID# 252172
state: Kanagawa
city: Kuse District
country: Japan
facility: Kyoto Okamoto Memorial Hospital /ID# 255153
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 261970
state: Kyoto
city: Hyuga-shi
country: Japan
facility: Chiyoda Hospital /ID# 251077
state: Miyazaki
city: Miyakonojo
country: Japan
facility: National Hospital Organization Miyakonojo Medical Center /ID# 268280
state: Miyazaki
city: Sakaki
country: Japan
facility: Yoshida Internal Medicine Clinic - Sakaki /ID# 268285
state: Nagano
city: Nishisonogi-gun
country: Japan
facility: Nagasaki Kita Hospital /ID# 266672
state: Nagasaki
city: Sasebo-shi
country: Japan
facility: Sasebo Chuo Hospital /ID# 253202
state: Nagasaki
city: Tenri-shi
country: Japan
facility: Tenri Hospital /ID# 256996
state: Nara
city: Oita-shi
country: Japan
facility: Oribe Clinic of Rheumatism and Medicine /ID# 251079
state: Oita
city: Kawachinagano Shi
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center /ID# 251072
state: Osaka
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic /ID# 251070
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City General Hospital /ID# 258202
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 254436
state: Osaka
city: Osaka-shi
country: Japan
facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital /ID# 260159
state: Osaka
city: Yaizu City
country: Japan
facility: Koga Community Hospital /ID# 251074
state: Shizuoka
city: Anan-shi
country: Japan
facility: Anan Medical Center /ID# 268818
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 251103
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital /ID# 252569
state: Tokyo
city: Chuo-ku
country: Japan
facility: Suzuki Clinic Orthopaedics River City /ID# 254482
state: Tokyo
city: Meguro
country: Japan
facility: National Hospital Organization Tokyo Medical Center /ID# 270441
state: Tokyo
city: Suginami -ku
country: Japan
facility: Meiyo Immunology & Rheumatology Clinic /ID# 256176
state: Tokyo
city: 荒川区
country: Japan
facility: Nishiogu Clinic /ID# 266670
state: Tokyo
city: Nakaniikawa-gun
country: Japan
facility: 500koku Orthopedic Clinic /ID# 268283
state: Toyama
city: Takaoka-shi
country: Japan
facility: Takaoka Rheumatic Orthopedic Clinic /ID# 252895
state: Toyama
city: Toyama-shi
country: Japan
facility: Toyama University Hospital /ID# 251682
state: Toyama
city: Fuefuki-shi
country: Japan
facility: Kasugai Clinic /ID# 253201
state: Yamanashi
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital /ID# 266669
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: