Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets

Crohn Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03090139
• Other study ID #: IBD-5001
• Status: Completed
• Start date: March 28, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: June 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1731
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Necrosis
• Ulcer

Intervention

Drug:
• Anti-TNF Therapy
Anti-TNF therapy.

Locations

Country	Name	City	State
Argentina	Hospital Aleman	Ciudad Autonoma Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Hospital Italiano	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	Hospital Privado Centro Medico de Cordoba	Cordoba
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
China	Peking Union Medical College Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Sixth Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.	Huangpu	Shanghai
China	The Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu
China	No. 10 People's Hospital of Shanghai	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
Colombia	Hospital Militar Central	Bogota
Colombia	Hospital Universitario San Ignacio	Bogota
Colombia	Institucion Mediservis Tolima IPS S.A.S	Ibague
Colombia	Hospital Pablo Tobon Uribe	Medellin
Colombia	Instituto de Coloproctologia ICO S.A.S.	Medellin
Korea, Republic of	Hanyang University Guri Hospital	Guri-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gangwon-do
Mexico	Hospital Medica Sur	Distrito Federal
Mexico	Investigacion Clinica de Leon S.C.	Leon	Guanajuato
Mexico	Centro de Investigacion Clinica Acelerada, S.C.	Mexico	Distrito Federal
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran	Mexico	Distrito Federal
Mexico	Centro Regiomontano de Estudios Clinicos Roma S.C.	Monterrey	Nuevo Leon
Mexico	Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca	Toluca de Lerdo	Estado De Mexico
Russian Federation	The Saint Ioasaf Belgorod Regional Hospital	Belgorod
Russian Federation	Irkutsk State Regional Hospital	Irkutsk
Russian Federation	Kazan State Medical University	Kazan
Russian Federation	FSBI State Scientific Centre of Coloproctology" of the MoH of RF	Moscow
Russian Federation	Moscow Clinical Research Center	Moscow
Russian Federation	Moscow Region Research Cliniucal Institute	Moscow
Russian Federation	SBIH City Clinical Hospital #31	Saint Petersburg
Russian Federation	Llc "Riat"	Saint-Petersburg
Russian Federation	Pokrovskaya Municipal Hospital	Saint-Petersburg
Russian Federation	FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation	Stavropol
Saudi Arabia	King Fahd General Hospital	Jeddah
Saudi Arabia	King Khalid National Guard Hospital	Jeddah
Saudi Arabia	King Fahd University Hospital	Khobar
Saudi Arabia	King Fahd Medical City	Riyadh
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
Saudi Arabia	King Khalid University Hospital	Riyadh
Singapore	Changi General Hospital- Parent	Singapore
Singapore	CJ Ooi Gastroenterology Clinic Pte Ltd	Singapore
Singapore	National University Cancer Institute,	Singapore
Singapore	Singapore General Hospital- Parent	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Baskent University Ankara Hospital	Ankara
Turkey	Gazi University Medical Faculty	Ankara
Turkey	Turkiye Yuksek Ihtisas Training and Research Hospital	Ankara
Turkey	Gaziantep University Medical Faculty Sahinbey Educational Research Hospital	Gaziantep
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Haydarpasa Numune Training and Research Hospital	Istanbul
Turkey	Istanbul Medeniyet Uni Goztepe Training&Res Hosp	Istanbul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Izmir Katip Celebi Univ. Ataturk Training and Research Hospital	Izmir
Turkey	Inonu Uni. Med. Fac.	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Argentina,  China,  Colombia,  Korea, Republic of,  Mexico,  Russian Federation,  Saudi Arabia,  Singapore,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Sub-optimal Response in UC and CD Participants	Incidence rate will be calculated as the number of events divided by the total person time at risk, for participants under anti-TNF therapy.	5 years
Primary	Treatment Patterns in UC and CD Participants		5 years
Primary	Number of Participants With Each Type of Anti-TNF Therapy		5 years
Primary	Duration of Treatment		5 years
Primary	Number of Participants With Response to Treatment	Number of participants with response to treatment will be assessed.	5 years
Primary	Treatment Pattern Results Stratified by Anti-TNF Response Group and by UC or CD Diagnosis	Treatment patterns results were as per the Anti-TNF therapy response from UC and CD participants.	5 years
Primary	Time-to-switch	The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.	5 years
Primary	Time-to-first Indicator of Sub-optimal Therapy	Time-to-first indicator of sub-optimal therapy was defined as the occurrence of dose escalation, therapy augmentation, therapy switch, therapy discontinuation, hospitalization, or surgery of participant, which ever occurred first.	5 years
Secondary	Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI)	Clinical response is defined as a decrease in HBI score of greater than or equal to (>=) 3 points from baseline. HBI score is used to measure the disease activity of CD. It consists of clinical parameters: abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.	Baseline up to 5 years
Secondary	Number of Participants With UC Achieving Clinical Response Based on Mayo Scores	Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and >=25% from baseline, with an accompanying decrease in rectal bleeding subscore of >=1 point from baseline or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consists of 3 subscores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.	Baseline up to 5 years
Secondary	Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation	IBD-related surgeries and hospitalisation will be conducted in the two years prior to index anti-TNF therapy in UC or CD participants.	2 years prior to index anti-TNF therapy
Secondary	Number of Participants with Co-morbidities		Baseline
Secondary	Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants	The predictors of sub-optimal response will be assessed through multivariate analysis using logistic regression or other appropriate statistical methods. Multivariate analyses may be conducted to derive predictors of sub-optimal response to anti-TNF therapy globally and individually.	Baseline up to 5 years
Secondary	Health Care Resources Utilisation (HCRU)	HCRU will be calculated for physician clinic visits, emergency department visits, IBD-related surgeries, invasive procedures, imaging, and in-participant admissions related to UC or CD, or related complications as available in the medical record and captured in the electronic case report form (eCRF).	Baseline up to 7 years
Secondary	Physician Survey Questionnaire	The physician survey questionnaire will include questions on local accessibility to infusion centres, potential restrictions of prescription, potential local difficulties for drug access (example, reimbursement process, economic burden), and other reasons for participants compliant with the local label to not receive anti-TNF therapy.	Baseline