A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
- Conditions
- Colitis, UlcerativeCrohn DiseaseInflammatory Bowel Diseases
- Registration Number
- NCT03532932
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1990
- Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
- 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.
- Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.
- Current or previous (within the last two years) indeterminate or not classified colitis.
- Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.
- Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.
- Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) 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).
- Secondary Outcome Measures
Name Time Method Number of Participants Stratified by Location of Disease Within 1 year prior to Baseline (Visit 1) Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice From Baseline Visit (Day 1) up to 12 months 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.
UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period 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.
CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period 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.
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) Number of Participants Stratified by Disease Severity At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period 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.
Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) 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.
Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity From Baseline Visit (Day 1) up to 12 months 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.
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 From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) 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.
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 after enrollment (up to 3 years) "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).
Trial Locations
- Locations (34)
Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department
🇰🇿Almaty, Almaty Region, Kazakhstan
State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital
🇷🇺Irkutsk, Irkutsk Region, Russian Federation
Budgetary Institution "Surgut District Clinical Hospital"
🇷🇺Surgut, Khanty-Mansi Autonomous Okrug-Yugra, Russian Federation
State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".
🇷🇺Krasnodar, Krasnodar Region, Russian Federation
St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"
🇷🇺Saint-Petersburg, Leningrad Region, Russian Federation
State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy
🇷🇺Moscow, Moscow Region, Russian Federation
Society with limited liability "Medical Association" New Hospital "
🇷🇺Ekaterinburg, Sverdlovsk Region, Russian Federation
Republican Clinical Hospital Ministry of health Republic of Tatarstan
🇷🇺Kazan, Tatarstan Republic, 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
State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"
🇷🇺Kemerovo, Kemerovo Region, Russian Federation
The Centre of Coloproctology based at City Hospital 1
🇰🇿Astana, Astana Region, Kazakhstan
Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon
🇷🇺Krasnoyarsk, Krasnoyarsk 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
Perm regional clinical hospital
🇷🇺Perm, Perm Region,, Russian Federation
State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"
🇷🇺Simferopol, Republic Crimea, Russian Federation
State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov
🇷🇺Ufa, Ufa Region, Russian Federation
MEDSI Clinical Hospital
🇷🇺Krasnogorsk, Moscow 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 Institution of Ryazan Region "City Clinical Hospital #4"
🇷🇺Ryazan, Ryazan Region, Russian Federation
Republican Gastroenterology Center, City Clinical Hospital # 10
🇧🇾Minsk, Minsk Region, Belarus
Regional clinical hospital
🇰🇿Shymkent, Shymkent Region, Kazakhstan
Regional Clinical Hospital
🇷🇺Vladimir, Vladimir Region, 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 Healthcare Institution Ulyanovsk Regional Clinical Hospital
🇷🇺Ulyanovsk, Ulyanovsk Region, Russian Federation
Vitebsk regional clinical specialized center
🇧🇾Vitebsk, Vitebsk Region, Belarus
State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"
🇷🇺Chelyabinsk, Chelyabinsk Region, Russian Federation
Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"
🇷🇺Khabarovsk, Khabarovsk Territory, Russian Federation
Scientific and Research Center "Eco-safety", LLC
🇷🇺Saint-Petersburg, Leningrad Region, Russian Federation
State Scientific Center of Coloproctology
🇷🇺Moscow, Moscow Region, Russian Federation
Health Care Unit # 1 of Yoshkar-Ola city
🇷🇺Yoshkar-Ola, Republic Of Maruy El, 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
Moscow Clinical Scientific Center
🇷🇺Moscow, Moscow Region, Russian Federation
Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"
🇷🇺Petrozavodsk, Republic Of Karelia, Russian Federation