A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice (INTENT)

International, Multicentre, Non-Interventional Study To Evaluate Disease Control And Treatment Pattern In Patients With Moderate To Severe Inflammatory Bowel Disease In Real Life Practice

The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Detailed Description

This is a non-interventional, retrospective and prospective study of participants with IBD. This study will collect data to provide accurate and comprehensive information related to treatment patterns associated with biologics use or non-biological therapy in participants with moderate to severe UC and CD in routine clinical practice.

The study will have retrospective data collection from past records of participants within the last 2 years before participant's enrollment. The prospective part of the study will include one year of observation and data collection after the participant's enrollment in the study.

The study will enroll approximately 2000 participants. Participants will be enrolled in one of the two groups:

• UC Participants
• CD Participants

This multi-center trial will be conducted in Russia, Belarus and Kazakhstan. The overall period of observation in this study will be approximately 12 months. Participants will make 2 visits within their routine practice to the clinic after the enrollment into the study including a final visit at Month 12.

• Study Type: Observational
• Enrollment (Actual): 1990

Contacts and Locations

Study Locations

• Belarus
  • Minsk Region
    • Minsk, Minsk Region, Belarus, 220077
      • Republican Gastroenterology Center, City Clinical Hospital # 10
  • Vitebsk Region
    • Vitebsk, Vitebsk Region, Belarus, 210601
      • Vitebsk Regional Clinical Specialized Center
• Kazakhstan
  • Almaty Region
    • Almaty, Almaty Region, Kazakhstan, 050000
      • Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department
  • Astana Region
    • Astana, Astana Region, Kazakhstan, 010000
      • The Centre of Coloproctology based at City Hospital 1
  • Shymkent Region
    • Shymkent, Shymkent Region, Kazakhstan, 160000
      • Regional Clinical Hospital
• Russian Federation
  • Altai Territory
    • Barnaul, Altai Territory, Russian Federation, 656024
      • Regional Clinical Hospital
  • Chelyabinsk Region
    • Chelyabinsk, Chelyabinsk Region, Russian Federation, 454076
      • State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"
  • Irkutsk Region
    • Irkutsk, Irkutsk Region, Russian Federation, 664049
      • State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital
  • Kemerovo Region
    • Kemerovo, Kemerovo Region, Russian Federation, 650066
      • State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"
  • Khabarovsk Territory
    • Khabarovsk, Khabarovsk Territory, Russian Federation, 680009
      • Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"
  • Khanty-Mansi Autonomous Okrug-Yugra
    • Surgut, Khanty-Mansi Autonomous Okrug-Yugra, Russian Federation, 628408
      • Budgetary Institution "Surgut District Clinical Hospital"
  • Krasnodar Region
    • Krasnodar, Krasnodar Region, Russian Federation, 350086
      • State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".
  • Krasnoyarsk Region
    • Krasnoyarsk, Krasnoyarsk Region, Russian Federation, 660123
      • Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon
  • Leningrad Region
    • Saint-Petersburg, Leningrad Region, Russian Federation, 194044
      • Federal State Budget Military Educational Institution of Higher Education "Military Medical Academy named after S.Kirov" of the Ministry of Defense of the Russian Federation
    • Saint-Petersburg, Leningrad Region, Russian Federation, 196143
      • Scientific and Research Center "Eco-safety", LLC
    • Saint-Petersburg, Leningrad Region, Russian Federation, 197110
      • St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"
  • Moscow Region
    • Krasnogorsk, Moscow Region, Russian Federation, 150062
      • MEDSI Clinical Hospital
    • Moscow, Moscow Region, Russian Federation, 111123
      • Moscow Clinical Scientific Center
    • Moscow, Moscow Region, Russian Federation, 123423
      • State Scientific Center of Coloproctology
    • Moscow, Moscow Region, Russian Federation, 129110
      • State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy
  • Omsk Region
    • Omsk, Omsk Region, Russian Federation, 644111
      • Regional Clinical Hospital
  • Perm Region,
    • Perm, Perm Region,, Russian Federation, 614990
      • Perm Regional Clinical Hospital
  • Republic Crimea
    • Simferopol, Republic Crimea, Russian Federation, 295007
      • Medical Academy n. a. S. I. Georgievksiy Federal State Autonomous Educational Institution of Higher Education "Crimean State University n. a. V.I. Vernadskiy
    • Simferopol, Republic Crimea, Russian Federation, 295017
      • State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"
  • Republic Of Bashkortostan
    • Ufa, Republic Of Bashkortostan, Russian Federation, 450008
      • Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
  • Republic Of Karelia
    • Petrozavodsk, Republic Of Karelia, Russian Federation, 185910
      • Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"
  • Republic Of Maruy El
    • Yoshkar-Ola, Republic Of Maruy El, Russian Federation, 424037
      • Health Care Unit # 1 of Yoshkar-Ola city
  • Republic Of Udmurtia
    • Izhevsk, Republic Of Udmurtia, Russian Federation, 426039
      • Budgetary Institution of Health in the Republic of Udmurtia First Republican Clinical Hospital under the Ministry of Health, the Republic of Udmurtia
  • Ryazan Region
    • Ryazan, Ryazan Region, Russian Federation, 390023
      • State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"
  • Sverdlovsk Region
    • Ekaterinburg, Sverdlovsk Region, Russian Federation, 620109
      • Society with limited liability "Medical Association" New Hospital "
  • Tatarstan Republic
    • Kazan, Tatarstan Republic, Russian Federation, 20064
      • Republican Clinical Hospital Ministry of Health Republic of Tatarstan
  • Transbaikal Region
    • Chita, Transbaikal Region, Russian Federation, 672000
      • Federal State Budgetary Educational Institution of Higher Education "Chita state medical academy" of the Ministry of Health of the Russian Federation
  • Ufa Region
    • Ufa, Ufa Region, Russian Federation, 450005
      • State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov
    • Ufa, Ufa Region, Russian Federation, 450071
      • State Budgetary Healthcare Institution City Clinical Hospital 21
  • Ulyanovsk Region
    • Ulyanovsk, Ulyanovsk Region, Russian Federation, 432017
      • State Healthcare Institution Ulyanovsk Regional Clinical Hospital
  • Vladimir Region
    • Vladimir, Vladimir Region, Russian Federation, 600023
      • Regional Clinical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.

Description

Inclusion Criteria:

1. Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation.
3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.

Exclusion Criteria:

1. Current or previous (within the last two years) indeterminate or not classified colitis.
2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.
3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.
4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
UC Participants; Participants diagnosed with moderate to severe UC from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in UC participants particularly on the use of available biological therapies.
CD Participants; Participants diagnosed with moderate to severe CD from approximately 35 investigational sites will be observed retrospectively for previous 2 years before enrollment until Visit 1 and will be observed prospectively for 1 year after participant's enrollment into the study to assess treatment patterns and treatment outcomes in CD participants particularly on the use of available biological therapies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD	Treatment pattern with biologics agents or non-biological therapy included unique treatments combinations, Like>5-ASA1(Start with 5-ASA:5-ASA→Systemic biologics [SB] +/- STER+/-standard therapy[ST]),>5ASA2(without [w/o] STER),>5ASA3(5-ASA→STER+/-ST),>5ASA4(5-ASA→IS),>5ASA 5(5-ASA→5-ASA+/-IS),>5ASA6(5-ASA→ NOTR),>5ASA7(5-ASA),>NOTR1(NOTR→Biologics [BIO]+/-ST+/-STER),>NOTR 2(TR→ST+/-STER),>NOTR 3(NOTR),>IS1(IS→SB+STER+/-ST),>IS2(IS→SB+ST w/o STER),>IS 3(IS→STER+/-ST),>IS4(IS→5-ASA),>IS5(IS→NOTR),>IS6(IS→5-ASA+IS),>IS7(IS mono),>IS+5ASA1(IS+5-ASA→SB +/-ST),>IS+5ASA2(IS+5-ASA→SB ±ST w/o STER),>IS+5ASA3(IS+5-ASA→STER+/-ST),>IS+5ASA4(IS+5-ASA→NOTR),>IS+5ASA5(IS+5-ASA→IS),>IS+5ASA6(IS+5-ASA→5-ASA),>IS+5ASA7(IS+5-ASA),>BIO1(SB+/-STER+/-ST→withdrawal [w/d] of SB+ST+/-STER),>BIO2(SB+/-STER+/-ST),>BIO3(SB+/-STER+/-ST→NOTR),>BIO4(SB+/-STER+/-ST→SB mono),>STER1(STER+/-ST→w/d of STER+SB+/-ST),>STER2(STER+/-ST→w/d of STER+ST),>STER3(STER+/-ST→SB+STER+/-ST),>STER4(STER+/-ST→NOTR),>STER5(STER+/-ST).	From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Stratified by Location of Disease		Within 1 year prior to Baseline (Visit 1)
Number of Participants Stratified by Disease Severity	Disease Severity was defined using Harvey-Bradshaw Index (HBI) and mayo index. HBI is validated clinical index for evaluation of CD disease severity, including the 5 categories: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score less than (<) 5 was remission, score 5-7 was mild activity, score 8-16 was moderate, and score >16 was severe. Mayo index was used for evaluation of UC disease severity. Mayo index is an instrument consisting of 4 categories of: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each sub score graded from 0 to 3. The score ranges from 0 to 12, where score <2 was remission, score 3-5 was mild, score 6-10 was moderate, and score >10 was severe.	At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice	Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, magnetic resonance imaging (MRI) and ultrasound examination. Number of participants whose disease activity was evaluated using the respective methods were reported.	From Baseline Visit (Day 1) up to 12 months
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity	Disease activity assessment was performed using following methods- biomarkers, endoscopy, biopsy, X-ray, MRI and ultrasound examination. Biomarkers was based on evaluation of C-reactive protein (CRP) and/or fecal calprotectin levels. Endoscopy included colonoscopy/rectoromanoscopy/sigmoidoscopy and/or video capsule endoscopy and/or esophagogastroduodenoscopy (in the presence or suspicion of the presence of lesions of the upper gastrointestinal tract in Crohn's disease), X-ray was used for examination of the intestine to exclude stricturing and other lesions, MRI was used for examination of the intestine to exclude stricturing and other lesions using MRI and ultrasound for examination of the intestine to exclude stricturing and other lesions. Number of assessments using different methods in participants with UC and CD disease activity was summarized for specified methods and reported in terms of mean and standard deviation.	From Baseline Visit (Day 1) up to 12 months
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index	The full Mayo index is an instrument to measure disease activity of UC. It consists of 4 parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score ranged from 0 (normal or inactive disease) to 3 (severe activity). The score ranged from 0 to 12, where score <2 was remission, score 3-5 was mild activity, score 6-10 was moderate activity, and score >10 was severe activity. Higher scores indicating higher disease activity.	At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI	HBI was used for evaluation of CD remission. It is a validated clinical index for CD, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25, where score <5 was remission, score 5-7 was mild activity, score 8-16 was moderate activity, and score >16 was severe activity. Higher scores indicating higher disease activity.	At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy		From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment		From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Percentage of Participants Stratified by Achieving the Treatment Goals	Treat to target (T2T) approach was used for assessment of treatment goals. A "Treat to target" approach for UC included clinical remission (defined as resolution of rectal bleeding and diarrhea/altered bowel habit) and endoscopic remission (defined as Mayo endoscopic subscore of 0-1). Biomarker remission (normal C-reactive protein [CRP] and calprotectin) was considered as an adjunctive target. Histological remission was considered as an adjunctive goal. Clinical remission for CD was defined as resolution of abdominal pain and diarrhea/altered bowel habit. Endoscopic remission for CD was defined as resolution of ulceration at ileocolonoscopy or resolution of findings of inflammation on cross-sectional imaging in participants who cannot be adequately assessed with ileocolonoscopy. Biomarker remission (normal CRP and faecal calprotectin) was considered as an adjunctive target.	From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice	"Other" challenges included absence or inaccessibility of MRI (technical problems), participants financial difficulties, disability and bureaucratic problems, unavailability of biotherapy, limited quotas, referral of participants to other centers, absence of biotherapy treatment quotas, difficulty in performing computed tomography (CT).	From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD		From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries	Indications for surgical treatment included aggravation, intestinal bleeding, colon perforation, internal fistulas, abdominal cavity infiltrate, Interintestinal or Intraabdominal abscess, strictures in the gastrointestinal tract, anal fissures, and other. Types of surgeries includes both emergency and planned.	From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): November 8, 2021
• Study Completion (Actual): November 8, 2021

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Colitis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis, Ulcerative
• Other Study ID Numbers: IBD-5005; U1111-1207-6263 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No