Clinical trial NCT03090139: Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets
Official title: Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 1731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of participants with a diagnosis of CD or UC who were naive to anti-TNF therapy and received their first dose of anti-TNF treatment for CD or UC during the eligibility period at private and public sites that routinely treat IBD participants and prescribe anti-TNF therapy from the targeted countries of interest.

Brief summary: The purpose of this study is to establish the incidence of sub-optimal response to anti-TNF therapy in UC and CD participants.

Detailed description: Participants with historical diagnosis of CD and UC who were naïve to anti-TNF therapy were observed in this retrospective study. The study will look to identify the local barriers in prescribing anti-TNF therapy, treatment patterns and indicators of sub-optimal response to anti-TNF therapy in UC and CD participants in real-world clinical practice in the EM countries, along with the associated incidence of sub-optimal response and impact on health care resource utilization (HCRU). The will enroll approximately 2000 participants.

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.

Eligibility criteria: Inclusion Criteria:

1. Who are 18 years or older at Index Date and diagnosed with UC or CD.
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:

1. Diagnosed with indeterminate/unspecified type of IBD.
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.

Primary outcomes:
measure: Incidence Rate of Sub-optimal Response in UC and CD Participants
timeFrame: 5 years
measure: Treatment Patterns in UC and CD Participants
timeFrame: 5 years
measure: Number of Participants With Each Type of Anti-TNF Therapy
timeFrame: 5 years
measure: Duration of Treatment
timeFrame: 5 years
measure: Number of Participants With Response to Treatment
timeFrame: 5 years
measure: Treatment Pattern Results Stratified by Anti-TNF Response Group and by UC or CD Diagnosis
timeFrame: 5 years
measure: Time-to-switch
timeFrame: 5 years
measure: Time-to-first Indicator of Sub-optimal Therapy
timeFrame: 5 years
Secondary outcomes:
measure: Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI)
timeFrame: Baseline up to 5 years
measure: Number of Participants With UC Achieving Clinical Response Based on Mayo Scores
timeFrame: Baseline up to 5 years
measure: Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation
timeFrame: 2 years prior to index anti-TNF therapy
measure: Number of Participants with Co-morbidities
timeFrame: Baseline
measure: Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants
timeFrame: Baseline up to 5 years
measure: Health Care Resources Utilisation (HCRU)
timeFrame: Baseline up to 7 years
measure: Physician Survey Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
city: Nanjing
country: China
facility: The Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Huangpu
country: China
facility: Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: No. 10 People's Hospital of Shanghai
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
state: Zhejiang
city: Bogota
country: Colombia
facility: Hospital Militar Central
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Ibague
country: Colombia
facility: Institucion Mediservis Tolima IPS S.A.S
city: Medellin
country: Colombia
facility: Instituto de Coloproctologia ICO S.A.S.
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon-do
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Mexico
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
state: Distrito Federal
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran
state: Distrito Federal
city: Toluca de Lerdo
country: Mexico
facility: Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca
state: Estado De Mexico
city: Leon
country: Mexico
facility: Investigacion Clinica de Leon S.C.
state: Guanajuato
city: Monterrey
country: Mexico
facility: Centro Regiomontano de Estudios Clinicos Roma S.C.
state: Nuevo Leon
city: Distrito Federal
country: Mexico
facility: Hospital Medica Sur
city: Belgorod
country: Russian Federation
facility: The Saint Ioasaf Belgorod Regional Hospital
city: Irkutsk
country: Russian Federation
facility: Irkutsk State Regional Hospital
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
city: Moscow
country: Russian Federation
facility: Moscow Clinical Research Center
city: Moscow
country: Russian Federation
facility: FSBI State Scientific Centre of Coloproctology" of the MoH of RF
city: Moscow
country: Russian Federation
facility: Moscow Region Research Cliniucal Institute
city: Saint Petersburg
country: Russian Federation
facility: SBIH City Clinical Hospital #31
city: Saint-Petersburg
country: Russian Federation
facility: Pokrovskaya Municipal Hospital
city: Saint-Petersburg
country: Russian Federation
facility: Llc "Riat"
city: Stavropol
country: Russian Federation
facility: FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation
city: Jeddah
country: Saudi Arabia
facility: King Khalid National Guard Hospital
city: Jeddah
country: Saudi Arabia
facility: King Fahd General Hospital
city: Khobar
country: Saudi Arabia
facility: King Fahd University Hospital
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
city: Riyadh
country: Saudi Arabia
facility: King Fahd Medical City
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Singapore
country: Singapore
facility: National University Cancer Institute,
city: Singapore
country: Singapore
facility: Singapore General Hospital- Parent
city: Singapore
country: Singapore
facility: CJ Ooi Gastroenterology Clinic Pte Ltd
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital- Parent
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Turkiye Yuksek Ihtisas Training and Research Hospital
city: Ankara
country: Turkey
facility: Baskent University Ankara Hospital
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty Sahinbey Educational Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Fulya Hospital
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp
city: Izmir
country: Turkey
facility: Izmir Katip Celebi Univ. Ataturk Training and Research Hospital
city: Malatya
country: Turkey
facility: Inonu Uni. Med. Fac.
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.