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

Completed

• Conditions: Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases
• Interventions: Drug: Anti-TNF Therapy

• Registration Number: NCT03090139
• Lead Sponsor: Takeda

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.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-24
• Study Start: 2017-03-28
• Status Verified: 2018-06
• Primary Completion: 2018-06-13
• Study Completion: 2018-06-13
• Last Update Submitted: 2018-06-22
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1731

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Anti-TNF Therapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Each Type of Anti-TNF Therapy	5 years
Number of Participants With Response to Treatment	5 years	Number of participants with response to treatment will be assessed.
Treatment Pattern Results Stratified by Anti-TNF Response Group and by UC or CD Diagnosis	5 years	Treatment patterns results were as per the Anti-TNF therapy response from UC and CD participants.
Time-to-switch	5 years	The time to switch at which the participant switched to another anti-TNF therapy will be evaluated.
Time-to-first Indicator of Sub-optimal Therapy	5 years	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.
Treatment Patterns in UC and CD Participants	5 years
Duration of Treatment	5 years
Incidence Rate of Sub-optimal Response in UC and CD Participants	5 years	Incidence rate will be calculated as the number of events divided by the total person time at risk, for participants under anti-TNF therapy.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With UC Achieving Clinical Response Based on Mayo Scores	Baseline up to 5 years	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.
Number of Participants with Predictors of Sub-optimal Therapy in UC or CD Participants	Baseline up to 5 years	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.
Number of Participants With CD Achieving Clinical Response Based on Harvey Bradshaw Index (HBI)	Baseline up to 5 years	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.
Number of Participants with Inflammatory Bowel Disease (IBD) Related Surgeries and Hospitalisation	2 years prior to index anti-TNF therapy	IBD-related surgeries and hospitalisation will be conducted in the two years prior to index anti-TNF therapy in UC or CD participants.
Number of Participants with Co-morbidities	Baseline
Health Care Resources Utilisation (HCRU)	Baseline up to 7 years	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).
Physician Survey Questionnaire	Baseline	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.

Trial Locations

Locations (76)

Hospital Privado Centro Medico de Cordoba; 🇦🇷 Cordoba, Argentina

Hospital Britanico de Buenos Aires; 🇦🇷 Ciudad Autonoma Buenos Aires, Argentina

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, 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

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

No. 10 People's Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, 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 Universitario San Ignacio; 🇨🇴 Bogota, Colombia

Yonsei University Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, 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

The Catholic University of Korea, St. Vincent's Hospital; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Moscow Clinical Research Center; 🇷🇺 Moscow, Russian Federation

Pokrovskaya Municipal Hospital; 🇷🇺 Saint-Petersburg, Russian Federation

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Baskent University Ankara Hospital; 🇹🇷 Ankara, Turkey

Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; 🇹🇷 Gaziantep, Turkey

Gazi University Medical Faculty; 🇹🇷 Ankara, Turkey

Istanbul University Cerrahpasa Medical Faculty; 🇹🇷 Istanbul, Turkey

Ankara University Medical Faculty; 🇹🇷 Ankara, Turkey

Turkiye Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Ankara, Turkey

Acibadem Fulya Hospital; 🇹🇷 Istanbul, Turkey

Haydarpasa Numune Training and Research Hospital; 🇹🇷 Istanbul, Turkey

Izmir Katip Celebi Univ. Ataturk Training and Research Hospital; 🇹🇷 Izmir, Turkey

Inonu Uni. Med. Fac.; 🇹🇷 Malatya, Turkey

Istanbul Medeniyet Uni Goztepe Training&Res Hosp; 🇹🇷 Istanbul, Turkey

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

Institucion Mediservis Tolima IPS S.A.S; 🇨🇴 Ibague, Colombia

Instituto de Coloproctologia ICO S.A.S.; 🇨🇴 Medellin, Colombia

Hospital Pablo Tobon Uribe; 🇨🇴 Medellin, Colombia

Instituto Nacional de Ciencias Medicas y Nutricion Dr. Salvador Zubiran; 🇲🇽 Mexico, Distrito Federal, Mexico

Centro de Investigacion Clinica Acelerada, S.C.; 🇲🇽 Mexico, Distrito Federal, Mexico

Centro de Investigacion y Manejo, Torre Medica Sanatorio Toluca; 🇲🇽 Toluca de Lerdo, Estado De Mexico, Mexico

Centro Regiomontano de Estudios Clinicos Roma S.C.; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Hospital Medica Sur; 🇲🇽 Distrito Federal, Mexico

Kazan State Medical University; 🇷🇺 Kazan, Russian Federation

The Saint Ioasaf Belgorod Regional Hospital; 🇷🇺 Belgorod, Russian Federation

Irkutsk State Regional Hospital; 🇷🇺 Irkutsk, Russian Federation

FSBI State Scientific Centre of Coloproctology" of the MoH of RF; 🇷🇺 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

FSBEI HE Stavropol State Medical University of Ministry of Healthcare of Russian Federation; 🇷🇺 Stavropol, Russian Federation

King Khalid National Guard Hospital; 🇸🇦 Jeddah, Saudi Arabia

King Fahd General Hospital; 🇸🇦 Jeddah, Saudi Arabia

King Faisal Specialist Hospital & Research Center; 🇸🇦 Riyadh, Saudi Arabia

National University Cancer Institute,; 🇸🇬 Singapore, Singapore

Singapore General Hospital- Parent; 🇸🇬 Singapore, Singapore

King Fahd University Hospital; 🇸🇦 Khobar, Saudi Arabia

King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia

King Fahd Medical City; 🇸🇦 Riyadh, Saudi Arabia

CJ Ooi Gastroenterology Clinic Pte Ltd; 🇸🇬 Singapore, Singapore

Changi General Hospital- Parent; 🇸🇬 Singapore, Singapore

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou; 🇨🇳 Taoyuan, Taiwan

Ruijin Hospital, Shanghai Jiaotong Uni. School of Med.; 🇨🇳 Huangpu, Shanghai, China

Investigacion Clinica de Leon S.C.; 🇲🇽 Leon, Guanajuato, Mexico

Hospital Militar Central; 🇨🇴 Bogota, Colombia