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

Crohn Disease Clinical Trial

— INTENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532932
• Other study ID #: IBD-5005
• Secondary ID: U1111-1207-6263
• Status: Completed
• Start date: July 20, 2018
• Est. completion date: November 8, 2021

Study information

• Verified date: September 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1990
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Belarus	Republican Gastroenterology Center, City Clinical Hospital # 10	Minsk	Minsk Region
Belarus	Vitebsk regional clinical specialized center	Vitebsk	Vitebsk Region
Kazakhstan	Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department	Almaty	Almaty Region
Kazakhstan	The Centre of Coloproctology based at City Hospital 1	Astana	Astana Region
Kazakhstan	Regional clinical hospital	Shymkent	Shymkent Region
Russian Federation	Regional Clinical Hospital	Barnaul	Altai Territory
Russian Federation	State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"	Chelyabinsk	Chelyabinsk Region
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Chita state medical academy" of the Ministry of Health of the Russian Federation	Chita	Transbaikal Region
Russian Federation	Society with limited liability "Medical Association" New Hospital "	Ekaterinburg	Sverdlovsk Region
Russian Federation	State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital	Irkutsk	Irkutsk Region
Russian Federation	Budgetary Institution of Health in the Republic of Udmurtia First Republican Clinical Hospital under the Ministry of Health, the Republic of Udmurtia	Izhevsk	Republic Of Udmurtia
Russian Federation	Republican Clinical Hospital Ministry of health Republic of Tatarstan	Kazan	Tatarstan Republic
Russian Federation	State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"	Kemerovo	Kemerovo Region
Russian Federation	Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"	Khabarovsk	Khabarovsk Territory
Russian Federation	State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".	Krasnodar	Krasnodar Region
Russian Federation	MEDSI Clinical Hospital	Krasnogorsk	Moscow Region
Russian Federation	Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon	Krasnoyarsk	Krasnoyarsk Region
Russian Federation	Moscow Clinical Scientific Center	Moscow	Moscow Region
Russian Federation	State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy	Moscow	Moscow Region
Russian Federation	State Scientific Center of Coloproctology	Moscow	Moscow Region
Russian Federation	Regional Clinical Hospital	Omsk	Omsk Region
Russian Federation	Perm regional clinical hospital	Perm	Perm Region,
Russian Federation	Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"	Petrozavodsk	Republic Of Karelia
Russian Federation	State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"	Ryazan	Ryazan Region
Russian Federation	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	Scientific and Research Center "Eco-safety", LLC	Saint-Petersburg	Leningrad Region
Russian Federation	St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"	Saint-Petersburg	Leningrad Region
Russian Federation	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	State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"	Simferopol	Republic Crimea
Russian Federation	Budgetary Institution "Surgut District Clinical Hospital"	Surgut	Khanty-Mansi Autonomous Okrug-Yugra
Russian Federation	Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation	Ufa	Republic Of Bashkortostan
Russian Federation	State Budgetary Healthcare Institution City Clinical Hospital 21	Ufa	Ufa Region
Russian Federation	State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov	Ufa	Ufa Region
Russian Federation	State Healthcare Institution Ulyanovsk Regional Clinical Hospital	Ulyanovsk	Ulyanovsk Region
Russian Federation	Regional Clinical Hospital	Vladimir	Vladimir Region
Russian Federation	Health Care Unit # 1 of Yoshkar-Ola city	Yoshkar-Ola	Republic Of Maruy El

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Belarus,  Kazakhstan,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Stratified by Location of Disease		Within 1 year prior to Baseline (Visit 1)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)