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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1207-6263 | Other Identifier | WHO |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Stratified by Location of Disease | Within 1 year prior to Baseline (Visit 1) | |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Gastroenterology Center, City Clinical Hospital # 10 | Minsk | Minsk Oblast | 220077 | Belarus | ||
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants diagnosed with moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD) were observed retrospectively within 2 years before enrollment and prospectively one year after enrollment. A total of 1990 participants were enrolled (signed informed consent) into the study, of which 89 were screen failures. 1901 participants started the study and were analyzed in the study.
Participants took part in the study at the 36 investigative sites in Russia, Belarus and Kazakhstan from 20 July 2018 to 08 November 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | UC Participants | Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2019 | Oct 27, 2022 |
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| At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 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) |
| 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) |
| 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) |
| 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) |
| Vitebsk regional clinical specialized center |
| Vitebsk |
| Vitebsk Oblast |
| 210601 |
| Belarus |
| Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department | Almaty | Almaty Region | 050000 | Kazakhstan |
| The Centre of Coloproctology based at City Hospital 1 | Astana | Astana | 010000 | Kazakhstan |
| Regional clinical hospital | Shymkent | Shymkent | 160000 | Kazakhstan |
| Regional Clinical Hospital | Barnaul | Altai Territory | 656024 | 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 | 450008 | Russia |
| State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital" | Chelyabinsk | Chelyabinsk Oblast | 454076 | Russia |
| State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital | Irkutsk | Irkutsk Oblast | 664049 | Russia |
| State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev" | Kemerovo | Kemerovo Oblast | 650066 | Russia |
| Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev" | Khabarovsk | Khabarovsk Territory | 680009 | Russia |
| Budgetary Institution "Surgut District Clinical Hospital" | Surgut | Khanty-Mansi Autonomous Okrug-Yugra | 628408 | Russia |
| State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky". | Krasnodar | Krasnodarskiy Kray | 350086 | Russia |
| Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon | Krasnoyarsk | Krasnoyarsk Region | 660123 | 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' | 194044 | Russia |
| Scientific and Research Center "Eco-safety", LLC | Saint-Petersburg | Leningradskaya Oblast' | 196143 | Russia |
| St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31" | Saint-Petersburg | Leningradskaya Oblast' | 197110 | Russia |
| MEDSI Clinical Hospital | Krasnogorsk | Moscow Oblast | 150062 | Russia |
| Moscow Clinical Scientific Center | Moscow | Moscow Oblast | 111123 | Russia |
| State Scientific Center of Coloproctology | Moscow | Moscow Oblast | 123423 | Russia |
| State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy | Moscow | Moscow Oblast | 129110 | Russia |
| Regional Clinical Hospital | Omsk | Omsk Oblast | 644111 | Russia |
| Perm regional clinical hospital | Perm | Perm Krai | 614990 | 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 | 295007 | Russia |
| State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko" | Simferopol | Republic Crimea | 295017 | Russia |
| Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University" | Petrozavodsk | Republic of Karelia | 185910 | Russia |
| Health Care Unit # 1 of Yoshkar-Ola city | Yoshkar-Ola | Republic of Maruy El | 424037 | Russia |
| State Budgetary Institution of Ryazan Region "City Clinical Hospital #4" | Ryazan | Ryazan Oblast | 390023 | Russia |
| Society with limited liability "Medical Association" New Hospital " | Yekaterinburg | Sverdlovsk Oblast | 620109 | Russia |
| Republican Clinical Hospital Ministry of health Republic of Tatarstan | Kazan' | Tatarstan Republic | 20064 | 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 | 426039 | Russia |
| State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov | Ufa | Ufa Region | 450005 | Russia |
| State Budgetary Healthcare Institution City Clinical Hospital 21 | Ufa | Ufa Region | 450071 | Russia |
| State Healthcare Institution Ulyanovsk Regional Clinical Hospital | Ulyanovsk | Ulyanovsk Oblast | 432017 | Russia |
| Regional Clinical Hospital | Vladimir | Vladimirskaya Oblast’ | 600023 | 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 | 672000 | Russia |
| FG001 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) included those participants who signed the informed consent form and were analyzed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | UC Participants | Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
| BG001 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Employment Status | Count of Participants | Participants |
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| Disability | Disability was determined based on participant's healthcare resources utilization. | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Age at Disease Onset | Mean | Standard Deviation | years |
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| Family History of Inflammatory Bowel Disease (IBD) | Participants were stratified by the following categories: with IBD history and without IBD history. | Count of Participants | Participants |
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| Clinical Course of IBD | Count of Participants | Participants |
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| Complications of IBD | Count of Participants | Participants |
| ||||||||||||||||
| Extraintestinal Manifestation (EIM) | Extraintestinal manifestation means when disease impacts other part of body. Between 25-40 percent (%) of IBD participants experience EIMs, commonly in the joints, skin, bones, eyes, kidneys, and liver. | Count of Participants | Participants |
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| Had Medical History | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Count of Participants | Participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| Secondary | Number of Participants Stratified by Location of Disease | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Within 1 year prior to Baseline (Visit 1) |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable at specified visits. | Posted | Count of Participants | Participants | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Count of Participants | Participants | From Baseline Visit (Day 1) up to 12 months |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Mean | Standard Deviation | assessments | From Baseline Visit (Day 1) up to 12 months |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Number | percentage of participants | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Number | percentage of participants | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period |
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| Secondary | Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Count of Participants | Participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| Secondary | Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for given categories. | Posted | Number | percentage of participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| 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). | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| 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 | FAS included those participants who signed the informed consent form and were analyzed in the study. | Posted | Number | percentage of participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
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| 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. | FAS included those participants who signed the informed consent form and were analyzed in the study. Here, number analyzed signifies participants who were evaluable for given categories. | Posted | Number | percentage of participants | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) |
|
Up to 12 months after enrollment into the study
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety data was not planned to be collected for this observational retrospective part of the study, however it was collected and assessed for the prospective part of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | UC Participants | Participants diagnosed with moderate to severe UC were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 3 | 1,214 | 146 | 1,214 | 48 | 1,214 |
| EG001 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. | 5 | 687 | 84 | 687 | 31 | 687 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal fistula | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Acute hepatitis C | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cervical leukoplakia | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Colitis ulcerative | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal stenosis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Enterocolonic fistula | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal resection | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Ileectomy | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Thyroidectomy | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Takayasu's arteritis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bicytopenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Gilbert's syndrome | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA | Systematic Assessment |
| |
| Drug resistance | General disorders | MedDRA | Systematic Assessment |
| |
| Drug intolerance | General disorders | MedDRA | Systematic Assessment |
| |
| Loss of therapeutic response | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatocellular injury | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Bartholin's abscess | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Cell death | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Cervical leukoplakia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Abscess drainage | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
| |
| Loss of therapeutic response | General disorders | MedDRA | Systematic Assessment |
| |
| Drug induced liver injury | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Alopecia totalis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Yellow skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 30, 2021 | Oct 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
|
| Tartarian |
|
| Ukrainian |
|
| Baskirian |
|
| Chuvash |
|
| Belarusian |
|
| Kazakh |
|
| Other |
|
| Kazakhstan |
|
| Russia |
|
| Unemployed |
|
| Pensioner |
|
| Student |
|
| Other |
|
| Had no Disability |
|
| Ex-smoker |
|
| Current Smoker |
|
| Without IBD History |
|
| Chronic Continuous Form (Absence of Remission Longer Than 6 months Despite Adequate Treatment) |
|
| Chronic Relapsing Course (With Remission Periods Longer Than 6 months) |
|
| Had no Complications of IBD |
|
| > 5ASA 3 |
|
| >5ASA 4 |
|
| >5ASA 5 |
|
| >5ASA 6 |
|
| >5ASA 7 |
|
| >BIO 1 |
|
| >BIO 2 |
|
| >BIO 3 |
|
| >BIO 4 |
|
| >Immunosuppressive (IS) 1 |
|
| >IS 2 |
|
| >IS 3 |
|
| >IS 4 |
|
| >IS 5 |
|
| >IS 6 |
|
| >IS 7 |
|
| >IS+5ASA 1 |
|
| >IS+5ASA 2 |
|
| >IS+5ASA 3 |
|
| >IS+5ASA 4 |
|
| >IS+5ASA 5 |
|
| >IS+5ASA 6 |
|
| >IS+5ASA 7 |
|
| >No IBD Therapy (NO TR) 1 |
|
| >NO TR 2 |
|
| >NO TR 3 |
|
| >Steroids (STER) 1 |
|
| >STER 2 |
|
| >STER 3 |
|
| >STER 4 |
|
| >STER 5 |
|
| Pattern with combination of biologics (BIO COMB) |
|
| Vedolizumab |
|
| Other |
|
| Participants |
|
|
| OG001 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| CD Participants |
Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | CD Participants | Participants diagnosed with moderate to severe CD were observed retrospectively for previous 2 years before enrollment until Baseline Visit 1 (Day 1) and further observed prospectively for 1 year after participants were enrolled into the study during Observational Visit 2 at 6 months and Final Visit 3 at 12 months to assess treatment patterns and treatment outcomes. |
|
|
|
|
| Participants |
|
|
|
|