Clinical trial NCT03532932: A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 1990
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Secondary outcomes:
measure: Number of Participants Stratified by Location of Disease
timeFrame: Within 1 year prior to Baseline (Visit 1)
measure: Number of Participants Stratified by Disease Severity
timeFrame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
measure: Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice
timeFrame: From Baseline Visit (Day 1) up to 12 months
measure: Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity
timeFrame: From Baseline Visit (Day 1) up to 12 months
measure: UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index
timeFrame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
measure: CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI
timeFrame: At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period
measure: Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
measure: Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
measure: Percentage of Participants Stratified by Achieving the Treatment Goals
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
measure: Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
measure: Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
measure: Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries
timeFrame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Republican Gastroenterology Center, City Clinical Hospital # 10
state: Minsk Region
city: Vitebsk
country: Belarus
facility: Vitebsk regional clinical specialized center
state: Vitebsk Region
city: Almaty
country: Kazakhstan
facility: Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department
state: Almaty Region
city: Astana
country: Kazakhstan
facility: The Centre of Coloproctology based at City Hospital 1
state: Astana Region
city: Shymkent
country: Kazakhstan
facility: Regional clinical hospital
state: Shymkent Region
city: Barnaul
country: Russian Federation
facility: Regional Clinical Hospital
state: Altai Territory
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"
state: Chelyabinsk Region
city: Irkutsk
country: Russian Federation
facility: State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital
state: Irkutsk Region
city: Kemerovo
country: Russian Federation
facility: State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"
state: Kemerovo Region
city: Khabarovsk
country: Russian Federation
facility: Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"
state: Khabarovsk Territory
city: Surgut
country: Russian Federation
facility: Budgetary Institution "Surgut District Clinical Hospital"
state: Khanty-Mansi Autonomous Okrug-Yugra
city: Krasnodar
country: Russian Federation
facility: State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".
state: Krasnodar Region
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon
state: Krasnoyarsk Region
city: Saint-Petersburg
country: Russian Federation
facility: 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
state: Leningrad Region
city: Saint-Petersburg
country: Russian Federation
facility: Scientific and Research Center "Eco-safety", LLC
state: Leningrad Region
city: Saint-Petersburg
country: Russian Federation
facility: St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"
state: Leningrad Region
city: Krasnogorsk
country: Russian Federation
facility: MEDSI Clinical Hospital
state: Moscow Region
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center
state: Moscow Region
city: Moscow
country: Russian Federation
facility: State Scientific Center of Coloproctology
state: Moscow Region
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy
state: Moscow Region
city: Omsk
country: Russian Federation
facility: Regional Clinical Hospital
state: Omsk Region
city: Perm
country: Russian Federation
facility: Perm regional clinical hospital
state: Perm Region,
city: Simferopol
country: Russian Federation
facility: Medical Academy n. a. S. I. Georgievksiy Federal State Autonomous Educational Institution of Higher Education "Crimean State University n. a. V.I. Vernadskiy
state: Republic Crimea
city: Simferopol
country: Russian Federation
facility: State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"
state: Republic Crimea
city: Ufa
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
state: Republic Of Bashkortostan
city: Petrozavodsk
country: Russian Federation
facility: Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"
state: Republic Of Karelia
city: Yoshkar-Ola
country: Russian Federation
facility: Health Care Unit # 1 of Yoshkar-Ola city
state: Republic Of Maruy El
city: Izhevsk
country: Russian Federation
facility: Budgetary Institution of Health in the Republic of Udmurtia First Republican Clinical Hospital under the Ministry of Health, the Republic of Udmurtia
state: Republic Of Udmurtia
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"
state: Ryazan Region
city: Ekaterinburg
country: Russian Federation
facility: Society with limited liability "Medical Association" New Hospital "
state: Sverdlovsk Region
city: Kazan
country: Russian Federation
facility: Republican Clinical Hospital Ministry of health Republic of Tatarstan
state: Tatarstan Republic
city: Chita
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Chita state medical academy" of the Ministry of Health of the Russian Federation
state: Transbaikal Region
city: Ufa
country: Russian Federation
facility: State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov
state: Ufa Region
city: Ufa
country: Russian Federation
facility: State Budgetary Healthcare Institution City Clinical Hospital 21
state: Ufa Region
city: Ulyanovsk
country: Russian Federation
facility: State Healthcare Institution Ulyanovsk Regional Clinical Hospital
state: Ulyanovsk Region
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
state: Vladimir Region
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: