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Colitis, UlcerativeNCT03090139

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

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 76 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anti-TNF Therapy
How many people
1,731 participants
Where
76 sitesin 10 countries
Study dates
28 Mar 2017to 13 Jun 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

76 sites in 10 countries.

76 sites in 10 countries

Turkey (Türkiye)11 sites

  • Ankara University Medical Faculty

    Ankara, 06100

  • Turkiye Yuksek Ihtisas Training and Research Hospital

    Ankara, 06100

  • Baskent University Ankara Hospital

    Ankara, 06490

  • Gazi University Medical Faculty

    Ankara, 06500

  • Gaziantep University Medical Faculty Sahinbey Educational Research Hospital

    Gaziantep, 27310

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Acibadem Fulya Hospital

    Istanbul, 34349

  • Haydarpasa Numune Training and Research Hospital

    Istanbul, 34668

  • Istanbul Medeniyet Uni Goztepe Training&Res Hosp

    Istanbul, 34854

  • Izmir Katip Celebi Univ. Ataturk Training and Research Hospital

    Izmir, 35965

  • Inonu Uni. Med. Fac.

    Malatya, 44280

Other trials in Turkey (Türkiye)

China10 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011

  • The Sixth Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

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

    Hangzhou, Zhejiang, 310016

  • Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.

    Huangpu, Shanghai Municipality, 200020

  • The Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • No. 10 People's Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200072

Other trials in China

Russia10 sites

  • The Saint Ioasaf Belgorod Regional Hospital

    Belgorod, 308007

  • Irkutsk State Regional Hospital

    Irkutsk, 664047

  • Kazan State Medical University

    Kazan', 420012

  • Moscow Clinical Research Center

    Moscow, 111123

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

    Moscow, 123423

  • Moscow Region Research Cliniucal Institute

    Moscow, 129110

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 195067

  • Llc "Riat"

    Saint Petersburg, 195220

  • SBIH City Clinical Hospital #31

    Saint Petersburg, 197110

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

    Stavropol, 355017

Other trials in Russia

South Korea10 sites

  • Hanyang University Guri Hospital

    Guri-si, Gyeonggi-do, 11923

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital, Yonsei University

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Suwon, Gyeonggi-do, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 26426

Other trials in South Korea

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 50004

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, 333

Other trials in Taiwan

Mexico6 sites

  • Hospital Medica Sur

    Distrito Federal, 14050

  • Investigacion Clinica de Leon S.C.

    León, Guanajuato, 37530

  • Centro de Investigacion Clinica Acelerada, S.C.

    Mexico City, Mexico City, 07020

  • Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran

    Mexico City, Mexico City, 14080

  • Centro Regiomontano de Estudios Clinicos Roma S.C.

    Monterrey, Nuevo León, 64610

  • Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca

    Toluca, State of Mexico, 50120

Other trials in Mexico

Saudi Arabia6 sites

  • King Khalid National Guard Hospital

    Jeddah, 21423

  • King Fahd General Hospital

    Jeddah, 21533

  • King Fahd University Hospital

    Khobar, 31952

  • King Khalid University Hospital

    Riyadh, 11462

  • King Fahd Medical City

    Riyadh, 14611

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 3354

Other trials in Saudi Arabia

Argentina5 sites

  • Hospital Italiano

    Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH

  • Hospital Aleman

    Ciudad Autonoma Buenos Aires, C1118AAT

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1280AEB

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900AXI

Other trials in Argentina

Colombia5 sites

  • Hospital Militar Central

    Bogotá, 00000

  • Hospital Universitario San Ignacio

    Bogotá, 00000

  • Institucion Mediservis Tolima IPS S.A.S

    Ibague, 730006

  • Instituto de Coloproctologia ICO S.A.S.

    Medellín, 050025

  • Hospital Pablo Tobon Uribe

    Medellín, 050034

Other trials in Colombia

Singapore5 sites

  • National University Cancer Institute,

    Singapore, 119074

  • Singapore General Hospital- Parent

    Singapore, 169608

  • CJ Ooi Gastroenterology Clinic Pte Ltd

    Singapore, 258499

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital- Parent

    Singapore, 529889

Other trials in Singapore

About this study

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)

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

Read the 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.

Being tested
Anti-TNF Therapy
Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-TNF TherapyDrug

    Anti-TNF therapy.

Study groups in NCT03090139
Study groupRoleWhat they receive
All ParticipantsAll 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.
Receives: Drug: Anti-TNF Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 5 years

  2. Treatment Patterns in UC and CD Participants

    Measured: 5 years

  3. Number of Participants With Each Type of Anti-TNF Therapy

    Measured: 5 years

  4. Duration of Treatment

    Measured: 5 years

  5. Number of Participants With Response to Treatment

    Number of participants with response to treatment will be assessed.

    Measured: 5 years

  6. 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.

    Measured: 5 years

  7. Time-to-switch

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

    Measured: 5 years

  8. 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.

    Measured: 5 years

Secondary outcomes (7)

  1. 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.

    Measured: Baseline up to 5 years

  2. 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.

    Measured: Baseline up to 5 years

  3. 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.

    Measured: 2 years prior to index anti-TNF therapy

  4. Number of Participants with Co-morbidities

    Measured: Baseline

  5. 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.

    Measured: Baseline up to 5 years

  6. 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).

    Measured: Baseline up to 7 years

  7. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start28 Mar 2017
  3. Primary completion13 Jun 2018
  4. Study completion13 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03090139
Sponsor's protocol ID
IBD-5001
Status last verified
Jun 2018
First submitted
22 Mar 2017
Last updated
26 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35120446

  • 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.

    PubMed 32563721

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 76 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in Turkey (Türkiye), China, Russia, South Korea, Taiwan and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rate of Sub-optimal Response in UC and CD Participants (time frame: 5 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03090139, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.

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