A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
NCT ID: NCT03532932
Last Updated: 2024-03-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1990 participants
OBSERVATIONAL
2018-07-20
2021-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)
NCT04873700
A Multicentered Prospective Cohort Study of Chinese IBD Patients
NCT05386290
Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease
NCT02335281
Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil
NCT02822235
Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets
NCT03090139
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Republican Gastroenterology Center, City Clinical Hospital # 10
Minsk, Minsk Oblast, Belarus
Vitebsk regional clinical specialized center
Vitebsk, Vitebsk Oblast, Belarus
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, Kazakhstan
Regional clinical hospital
Shymkent, Shymkent, Kazakhstan
Regional Clinical Hospital
Barnaul, Altai Territory, Russia
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Bashkortostan Republic, Russia
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"
Chelyabinsk, Chelyabinsk Oblast, Russia
State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, Russia
State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"
Kemerovo, Kemerovo Oblast, Russia
Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"
Khabarovsk, Khabarovsk Territory, Russia
Budgetary Institution "Surgut District Clinical Hospital"
Surgut, Khanty-Mansi Autonomous Okrug-Yugra, Russia
State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".
Krasnodar, Krasnodarskiy Kray, Russia
Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon
Krasnoyarsk, Krasnoyarsk Region, Russia
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, Leningradskaya Oblast', Russia
Scientific and Research Center "Eco-safety", LLC
Saint-Petersburg, Leningradskaya Oblast', Russia
St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"
Saint-Petersburg, Leningradskaya Oblast', Russia
MEDSI Clinical Hospital
Krasnogorsk, Moscow Oblast, Russia
Moscow Clinical Scientific Center
Moscow, Moscow Oblast, Russia
State Scientific Center of Coloproctology
Moscow, Moscow Oblast, Russia
State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy
Moscow, Moscow Oblast, Russia
Regional Clinical Hospital
Omsk, Omsk Oblast, Russia
Perm regional clinical hospital
Perm, Perm Krai, Russia
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, Russia
State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"
Simferopol, Republic Crimea, Russia
Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"
Petrozavodsk, Republic of Karelia, Russia
Health Care Unit # 1 of Yoshkar-Ola city
Yoshkar-Ola, Republic of Maruy El, Russia
State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"
Ryazan, Ryazan Oblast, Russia
Society with limited liability "Medical Association" New Hospital "
Yekaterinburg, Sverdlovsk Oblast, Russia
Republican Clinical Hospital Ministry of health Republic of Tatarstan
Kazan', Tatarstan Republic, Russia
Budgetary Institution of Health in the Republic of Udmurtia First Republican Clinical Hospital under the Ministry of Health, the Republic of Udmurtia
Izhevsk, Udmurtiya Republic, Russia
State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov
Ufa, Ufa Region, Russia
State Budgetary Healthcare Institution City Clinical Hospital 21
Ufa, Ufa Region, Russia
State Healthcare Institution Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Ulyanovsk Oblast, Russia
Regional Clinical Hospital
Vladimir, Vladimirskaya Oblast’, Russia
Federal State Budgetary Educational Institution of Higher Education "Chita state medical academy" of the Ministry of Health of the Russian Federation
Chita, Zabaykalskiy (Transbaikal) Kray, Russia
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1207-6263
Identifier Type: OTHER
Identifier Source: secondary_id
IBD-5005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.