A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice

NCT03532932 | Completed Results DMC

• 2 other identifiers: IBD-5005U1111-1207-6263
• Study Type: observational
• Target: 1,990
• Locations: 3 countries
• Sites: 36

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).

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (12)

• Number of Participants Stratified by Location of Disease

  Within 1 year prior to Baseline (Visit 1)

• Number of Participants Stratified by Disease Severity

  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

  From Baseline Visit (Day 1) up to 12 months

• Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity

  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

  At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (36)

Republican Gastroenterology Center, City Clinical Hospital # 10

Minsk, Minsk Oblast, 220077, Belarus

Location

Vitebsk regional clinical specialized center

Vitebsk, Vitebsk Oblast, 210601, Belarus

Location

Scientific-Research Institute of Cardiology and Internal Diseases, Gastroentorology department

Almaty, Almaty Region, 050000, Kazakhstan

Location

The Centre of Coloproctology based at City Hospital 1

Astana, Astana, 010000, Kazakhstan

Location

Regional clinical hospital

Shymkent, Shymkent, 160000, Kazakhstan

Location

Regional Clinical Hospital

Barnaul, Altai Territory, 656024, Russia

Location

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

Location

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"

Chelyabinsk, Chelyabinsk Oblast, 454076, Russia

Location

State Budgetary Healthcare Institution Irkutsk Order of the Badge of Honor Regional Clinical Hospital

Irkutsk, Irkutsk Oblast, 664049, Russia

Location

State Autonomous Healthcare Institution of Kemerovo region "Kemerovo regional clinical hospital n. a. S.V. Belyaev"

Kemerovo, Kemerovo Oblast, 650066, Russia

Location

Regional State Budgetary Healthcare Institution "Regional Clinical Hospital # 1 n. a. S.I. Sergeev"

Khabarovsk, Khabarovsk Territory, 680009, Russia

Location

Budgetary Institution "Surgut District Clinical Hospital"

Surgut, Khanty-Mansi Autonomous Okrug-Yugra, 628408, Russia

Location

State Budgetary Institution "Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky".

Krasnodar, Krasnodarskiy Kray, 350086, Russia

Location

Krasnoyarsk Interdistrict Clinical Hospital No. 20 named after IS Berzon

Krasnoyarsk, Krasnoyarsk Region, 660123, Russia

Location

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

Location

Scientific and Research Center "Eco-safety", LLC

Saint-Petersburg, Leningradskaya Oblast', 196143, Russia

Location

St. Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"

Saint-Petersburg, Leningradskaya Oblast', 197110, Russia

Location

MEDSI Clinical Hospital

Krasnogorsk, Moscow Oblast, 150062, Russia

Location

Moscow Clinical Scientific Center

Moscow, Moscow Oblast, 111123, Russia

Location

State Scientific Center of Coloproctology

Moscow, Moscow Oblast, 123423, Russia

Location

State Budgetary Healthcare Institution Moscow Regional Research and Clinical Institute (MONIKI) n. a. M. F. Vladimirskiy

Moscow, Moscow Oblast, 129110, Russia

Location

Regional Clinical Hospital

Omsk, Omsk Oblast, 644111, Russia

Location

Perm regional clinical hospital

Perm, Perm Krai, 614990, Russia

Location

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

Location

State Budgetary Healthcare Institution Republic of Crimea "Republican clinical hospital n.a. N.A.Semashko"

Simferopol, Republic Crimea, 295017, Russia

Location

Federal State Budget Educational Institution of Higher Education "Petrozavodsk State University"

Petrozavodsk, Republic of Karelia, 185910, Russia

Location

Health Care Unit # 1 of Yoshkar-Ola city

Yoshkar-Ola, Republic of Maruy El, 424037, Russia

Location

State Budgetary Institution of Ryazan Region "City Clinical Hospital #4"

Ryazan, Ryazan Oblast, 390023, Russia

Location

Society with limited liability "Medical Association" New Hospital "

Yekaterinburg, Sverdlovsk Oblast, 620109, Russia

Location

Republican Clinical Hospital Ministry of health Republic of Tatarstan

Kazan', Tatarstan Republic, 20064, Russia

Location

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

Location

State Budgetary Healthcare Institution RB Regional Clinical Hospital G.G Kuvatov

Ufa, Ufa Region, 450005, Russia

Location

State Budgetary Healthcare Institution City Clinical Hospital 21

Ufa, Ufa Region, 450071, Russia

Location

State Healthcare Institution Ulyanovsk Regional Clinical Hospital

Ulyanovsk, Ulyanovsk Oblast, 432017, Russia

Location

Regional Clinical Hospital

Vladimir, Vladimirskaya Oblast’, 600023, Russia

Location

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

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 22, 2018
• Study Start: July 20, 2018
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

KA (3); RU (31); BE (2)