INTENT: A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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UC Participants
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- Percentage of UC and CD Participants Treated with Biologics Observed for Treatment Patterns [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Treatment patterns planned to be observed in UC and CD participants treated with biologics according to drug name or drug type, initial dosage and changes during the course of treatment, overall duration of treatment, presence and reasons for interruption, and achievement of remission.
- Percentage of UC and CD Participants Treated with Non-biological Treatment Observed for Treatment Patterns [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Treatment patterns planned to be observed in UC and CD participants treated with non-biological treatment according to drug name or drug type, initial dosage and changes during the course of treatment, overall duration of treatment, presence and reasons for interruption, and achievement of remission.
Secondary Outcome Measures
- Percentage of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Methods for documentation of disease activity will include clinical, endoscopic, laboratory, and histological examinations.
- Percentage of Participants Based on Objective UC and CD Disease Activity Assessment Using Different Methods [From 2 years before enrollment up to Month 12 (approximately 3 years)]
- Percentage of Participants who Achieved Clinical and Combined Clinical and Endoscopic Remission [At enrollment, Months 6 and 12]
Treat to target (T2T) approach for UC includes clinical remission as a resolution of rectal bleeding and diarrhea/altered bowel habit, and endoscopic remission as Mayo endoscopic sub-score of 0 to 1. T2T approach for CD includes clinical remission as resolution of abdominal pain and diarrhea/altered bowel habit, and endoscopic remission for CD 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. Mayo score is an instrument used to measure disease activity. Mayo score evaluates UC stage based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation and physician's global assessment. Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity), with higher scores indicating more severe disease.
- Percentage of Participants with at least one Episode of Failure of Biological or Non-biological Therapy [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Failure of biological or non-biological therapy would include episodes of dose escalation of biologics, switching to another therapy, IBD-related surgery, and medication augmentation.
- Number of Participants Based on Treatment Decisions or Actions made after Making the Clinical Patterns of Treatment Decisions or Actions made after Assessment of IBD Activity Depending on Scenario of Achievement or Non-achievement of T2T Treatment Goals [From 2 years of enrollment up to Month 12 (approximately 3 years)]
Treatment decisions or actions depending on scenario of achievement or non-achievement of T2T treatment goals would include therapeutic de-escalation, escalation, without changes.
- Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Challenges of implementing T2T strategy will include clinicians related factors, patient related factors and disease related factors.
- Percentage of Participants with Hospitalizations due to Complications, IBD related Surgeries, and Disability Determination [From 2 years before enrollment up to Month 12 (approximately 3 years)]
- Percentage of Participants with Surgical Treatment Based on Indications, Types of Surgeries and Complications [From 2 years before enrollment up to Month 12 (approximately 3 years)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
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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.
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Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.
Exclusion Criteria:
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Current or previous (within the last two years) indeterminate or not classified colitis.
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Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.
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Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.
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Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Republican Gastroenterology Center, City Clinical Hospital # 10 | Minsk | Minsk Region | Belarus | 220077 |
| 2 | Vitebsk regional clinical specialized center | Vitebsk | Vitebsk Region | Belarus | 210601 |
| 3 | Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department | Almaty | Almaty Region | Kazakhstan | 050000 |
| 4 | The Centre of Coloproctology based at City Hospital 1 | Astana | Astana Region | Kazakhstan | 010000 |
| 5 | Regional clinical hospital | Shymkent | Shymkent Region | Kazakhstan | 160000 |
| 6 | Regional Clinical Hospital | Barnaul | Altai Territory | Russian Federation | 656024 |
| 7 | State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital" | Chelyabinsk | Chelyabinsk Region | Russian Federation | 454076 |
| 8 | State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital | Irkutsk | Irkutsk Region | Russian Federation | 664049 |
| 9 | State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev" | Kemerovo | Kemerovo Region | Russian Federation | 650066 |
| 10 | Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev" | Khabarovsk | Khabarovsk Territory | Russian Federation | 680009 |
| 11 | Budgetary Institution "Surgut District Clinical Hospital" | Surgut | Khanty-Mansi Autonomous Okrug-Yugra | Russian Federation | 628408 |
| 12 | State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky". | Krasnodar | Krasnodar Region | Russian Federation | 350086 |
| 13 | Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon | Krasnoyarsk | Krasnoyarsk Region | Russian Federation | 660123 |
| 14 | 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 | 194044 |
| 15 | Scientific and Research Center "Eco-safety", LLC | Saint-Petersburg | Leningrad Region | Russian Federation | 196143 |
| 16 | St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31" | Saint-Petersburg | Leningrad Region | Russian Federation | 197110 |
| 17 | MEDSI Clinical Hospital | Krasnogorsk | Moscow Region | Russian Federation | 150062 |
| 18 | Moscow Clinical Scientific Center | Moscow | Moscow Region | Russian Federation | 111123 |
| 19 | State Scientific Center of Coloproctology | Moscow | Moscow Region | Russian Federation | 123423 |
| 20 | State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy | Moscow | Moscow Region | Russian Federation | 129110 |
| 21 | Regional Clinical Hospital | Omsk | Omsk Region | Russian Federation | 644111 |
| 22 | Perm regional clinical hospital | Perm | Perm Region, | Russian Federation | 614990 |
| 23 | 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 | 295007 |
| 24 | State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko" | Simferopol | Republic Crimea | Russian Federation | 295017 |
| 25 | 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 | 450008 |
| 26 | Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University" | Petrozavodsk | Republic Of Karelia | Russian Federation | 185910 |
| 27 | Health Care Unit # 1 of Yoshkar-Ola city | Yoshkar-Ola | Republic Of Maruy El | Russian Federation | 424037 |
| 28 | 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 | 426039 |
| 29 | State Budgetary Institution of Ryazan Region "City Clinical Hospital #4" | Ryazan | Ryazan Region | Russian Federation | 390023 |
| 30 | Society with limited liability "Medical Association" New Hospital " | Ekaterinburg | Sverdlovsk Region | Russian Federation | 620109 |
| 31 | Republican Clinical Hospital Ministry of health Republic of Tatarstan | Kazan | Tatarstan Republic | Russian Federation | 20064 |
| 32 | 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 | 672000 |
| 33 | State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov | Ufa | Ufa Region | Russian Federation | 450005 |
| 34 | State Budgetary Healthcare Institution City Clinical Hospital 21 | Ufa | Ufa Region | Russian Federation | 450071 |
| 35 | State Healthcare Institution Ulyanovsk Regional Clinical Hospital | Ulyanovsk | Ulyanovsk Region | Russian Federation | 432017 |
| 36 | Regional Clinical Hospital | Vladimir | Vladimir Region | Russian Federation | 600023 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Medical Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IBD-5005
- U1111-1207-6263