Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets
NCT ID: NCT03090139
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1731 participants
OBSERVATIONAL
2017-03-28
2018-06-13
Brief Summary
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Detailed Description
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The study consists of two periods, eligibility period followed by a data abstraction period. During the eligibility period participants who had initiated first anti-TNF therapy during 01 March 2010 up to 01 March 2015 will be recruited and observed. Participants will be followed up for a period of minimum 2 years (other than death) and a maximum of 5 years from the date of first treatment of anti-TNF therapy for CD and UC (Index date). During the data abstraction period participants who have eligible medical charts will be identified and all retrospective data will be collected.
This multi-center trial will be conducted in Argentina, China, Colombia, Mexico, Russia, Saudi Arabia, Singapore, South Korea, Taiwan and Turkey. The overall time to abstract data during the data extraction period from the web-based electronic data capture (EDC) system will be approximately 1 year from March 2017 to February 2018.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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All Participants
All participants with diagnosis of UC and CD, who initiated treatment with anti-TNF therapy from 01 March 2010 up to 01 March 2015 will be observed. Retrospective data extraction will be done for eligible participants from March 2017 up to approximately February 2018.
Anti-TNF Therapy
Anti-TNF therapy.
Interventions
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Anti-TNF Therapy
Anti-TNF therapy.
Eligibility Criteria
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Inclusion Criteria
2. Who were naive to anti-TNF therapy and received their first dose of any anti-TNF therapy (index date) for UC or CD within the Eligibility Period from 01 March 2010 through 01 March 2015.
Exclusion Criteria
2. Were part of an IBD-related clinical trial during the observational period should be excluded (that is, index date up to the date of chart abstraction).
3. Who received an anti-TNF therapy for any non-UC or non-CD conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer).
4. Who received an anti-TNF/biologic therapy at any point that was administered outside of the labelled dosing regimen (example, episodic use of anti-TNF therapy).
5. With UC who had a total colectomy prior to their first anti-TNF therapy.
6. Charts not available.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Hospital Italiano
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Hospital Aleman
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
Huangpu, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
No. 10 People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Hospital Militar Central
Bogotá, , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Institucion Mediservis Tolima IPS S.A.S
Ibagué, , Colombia
Instituto de Coloproctologia ICO S.A.S.
Medellín, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Investigacion Clinica de Leon S.C.
León, Guanajuato, Mexico
Centro de Investigacion Clinica Acelerada, S.C.
Mexico City, Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, Mexico
Centro Regiomontano de Estudios Clinicos Roma S.C.
Monterrey, Nuevo León, Mexico
Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca
Toluca, State of Mexico, Mexico
Hospital Medica Sur
Distrito Federal, , Mexico
The Saint Ioasaf Belgorod Regional Hospital
Belgorod, , Russia
Irkutsk State Regional Hospital
Irkutsk, , Russia
Kazan State Medical University
Kazan', , Russia
Moscow Clinical Research Center
Moscow, , Russia
FSBI State Scientific Centre of Coloproctology" of the MoH of RF
Moscow, , Russia
Moscow Region Research Cliniucal Institute
Moscow, , Russia
Pokrovskaya Municipal Hospital
Saint Petersburg, , Russia
Llc "Riat"
Saint Petersburg, , Russia
SBIH City Clinical Hospital #31
Saint Petersburg, , Russia
FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation
Stavropol, , Russia
King Khalid National Guard Hospital
Jeddah, , Saudi Arabia
King Fahd General Hospital
Jeddah, , Saudi Arabia
King Fahd University Hospital
Khobar, , Saudi Arabia
King Khalid University Hospital
Riyadh, , Saudi Arabia
King Fahd Medical City
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, , Saudi Arabia
National University Cancer Institute,
Singapore, , Singapore
Singapore General Hospital- Parent
Singapore, , Singapore
CJ Ooi Gastroenterology Clinic Pte Ltd
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Changi General Hospital- Parent
Singapore, , Singapore
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, , Taiwan
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Turkiye Yuksek Ihtisas Training and Research Hospital
Ankara, , Turkey (Türkiye)
Baskent University Ankara Hospital
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
Gaziantep, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Acibadem Fulya Hospital
Istanbul, , Turkey (Türkiye)
Haydarpasa Numune Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Istanbul Medeniyet Uni Goztepe Training&Res Hosp
Istanbul, , Turkey (Türkiye)
Izmir Katip Celebi Univ. Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Inonu Uni. Med. Fac.
Malatya, , Turkey (Türkiye)
Countries
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References
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Li J, Liu Z, Hu P, Wen Z, Cao Q, Zou X, Chen Y, Wang Y, Zhong J, Shen X, Demuth D, Fadeeva O, Xie L, Chen J, Qian J. Indicators of suboptimal response to anti-tumor necrosis factor therapy in patients from China with inflammatory bowel disease: results from the EXPLORE study. BMC Gastroenterol. 2022 Feb 4;22(1):44. doi: 10.1186/s12876-021-02074-z.
Yamamoto-Furusho JK, Al Harbi O, Armuzzi A, Chan W, Ponce de Leon E, Qian J, Shapina M, Toruner M, Tu CH, Ye BD, Guennec M, Sison C, Demuth D, Fadeeva O, Khan QMR. Incidence of suboptimal response to tumor necrosis factor antagonist therapy in inflammatory bowel disease in newly industrialised countries: The EXPLORE study. Dig Liver Dis. 2020 Aug;52(8):869-877. doi: 10.1016/j.dld.2020.05.031. Epub 2020 Jun 17.
Other Identifiers
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IBD-5001
Identifier Type: -
Identifier Source: org_study_id
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