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

NCT03090139 | Completed

• 1 other identifier: IBD-5001
• Study Type: observational
• Target: 1,731
• Locations: 10 countries
• Sites: 76

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.

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (8)

• 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

• Treatment Patterns in UC and CD Participants

  5 years

• Number of Participants With Each Type of Anti-TNF Therapy

  5 years

• Duration of Treatment

  5 years

• Number of Participants With Response to Treatment

  Number of participants with response to treatment will be assessed.

  5 years

• 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

• Time-to-switch

  The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.

  5 years

• 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 Outcomes (7)

• Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI)

  Baseline up to 5 years

• Number of Participants With UC Achieving Clinical Response Based on Mayo Scores

  Baseline up to 5 years

• Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation

  2 years prior to index anti-TNF therapy

• Number of Participants with Co-morbidities

  Baseline

• Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants

  Baseline up to 5 years

Study Arms (1)

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.

Drug: Anti-TNF Therapy

Interventions

Anti-TNF Therapy DRUG

Anti-TNF therapy.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Diagnosed with indeterminate/unspecified type of IBD.
• 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).
• Who received an anti-TNF therapy for any non-UC or non-CD conditions (example, rheumatoid arthritis, ankylosing spondylitis, psoriasis, or cancer).
• 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).
• With UC who had a total colectomy prior to their first anti-TNF therapy.
• Charts not available.

Sponsors & Collaborators

• Takeda: lead

Study Sites (76)

Hospital Italiano

Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina

Location

Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AXI, Argentina

Location

Hospital Aleman

Ciudad Autonoma Buenos Aires, C1118AAT, Argentina

Location

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, C1280AEB, Argentina

Location

Hospital Privado Centro Medico de Cordoba

Córdoba, X5016KEH, Argentina

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

The Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

Huangpu, Shanghai Municipality, 200020, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

No. 10 People's Hospital of Shanghai

Shanghai, Shanghai Municipality, 200072, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Hospital Militar Central

Bogotá, 00000, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, 00000, Colombia

Location

Institucion Mediservis Tolima IPS S.A.S

Ibagué, 730006, Colombia

Location

Instituto de Coloproctologia ICO S.A.S.

Medellín, 050025, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, 050034, Colombia

Location

Investigacion Clinica de Leon S.C.

León, Guanajuato, 37530, Mexico

Location

Centro de Investigacion Clinica Acelerada, S.C.

Mexico City, Mexico City, 07020, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

Location

Centro Regiomontano de Estudios Clinicos Roma S.C.

Monterrey, Nuevo León, 64610, Mexico

Location

Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca

Toluca, State of Mexico, 50120, Mexico

Location

Hospital Medica Sur

Distrito Federal, 14050, Mexico

Location

The Saint Ioasaf Belgorod Regional Hospital

Belgorod, 308007, Russia

Location

Irkutsk State Regional Hospital

Irkutsk, 664047, Russia

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Moscow Clinical Research Center

Moscow, 111123, Russia

Location

FSBI State Scientific Centre of Coloproctology" of the MoH of RF

Moscow, 123423, Russia

Location

Moscow Region Research Cliniucal Institute

Moscow, 129110, Russia

Location

Pokrovskaya Municipal Hospital

Saint Petersburg, 195067, Russia

Location

Llc "Riat"

Saint Petersburg, 195220, Russia

Location

SBIH City Clinical Hospital #31

Saint Petersburg, 197110, Russia

Location

FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation

Stavropol, 355017, Russia

Location

King Khalid National Guard Hospital

Jeddah, 21423, Saudi Arabia

Location

King Fahd General Hospital

Jeddah, 21533, Saudi Arabia

Location

King Fahd University Hospital

Khobar, 31952, Saudi Arabia

Location

King Khalid University Hospital

Riyadh, 11462, Saudi Arabia

Location

King Fahd Medical City

Riyadh, 14611, Saudi Arabia

Location

King Faisal Specialist Hospital & Research Center

Riyadh, 3354, Saudi Arabia

Location

National University Cancer Institute,

Singapore, 119074, Singapore

Location

Singapore General Hospital- Parent

Singapore, 169608, Singapore

Location

CJ Ooi Gastroenterology Clinic Pte Ltd

Singapore, 258499, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital- Parent

Singapore, 529889, Singapore

Location

Yonsei University Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

Location

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital, Yonsei University

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Changhua Christian Hospital

Changhua, 50004, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Mackay Memorial Hospital

Taipei, 10449, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 333, Taiwan

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Turkiye Yuksek Ihtisas Training and Research Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Baskent University Ankara Hospital

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

Gaziantep, 27310, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Acibadem Fulya Hospital

Istanbul, 34349, Turkey (Türkiye)

Location

Haydarpasa Numune Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

Istanbul Medeniyet Uni Goztepe Training&Res Hosp

Istanbul, 34854, Turkey (Türkiye)

Location

Izmir Katip Celebi Univ. Ataturk Training and Research Hospital

Izmir, 35965, Turkey (Türkiye)

Location

Inonu Uni. Med. Fac.

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35120446 DERIVED

• 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.

  PMID: 32563721 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 24, 2017
• Study Start: March 28, 2017
• Primary Completion: June 13, 2018
• Study Completion: June 13, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

AR (5); CO (5); SG (5); KR (10); CN (10); ME (6); RU (10); TU (11); TW (8); SA (6)