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

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ClinicalTrials.gov Identifier: NCT03532932
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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
Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: International, Multicentre, Non-Interventional Study To Evaluate Disease Control And Treatment Pattern In Patients With Moderate To Severe Inflammatory Bowel Disease In Real Life Practice
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of UC and CD Participants Treated with Biologics Observed for Treatment Patterns [ Time Frame: 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.

  2. Percentage of UC and CD Participants Treated with Non-biological Treatment Observed for Treatment Patterns [ Time Frame: 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 :
  1. Percentage of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice [ Time Frame: 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.

  2. Percentage of Participants Based on Objective UC and CD Disease Activity Assessment Using Different Methods [ Time Frame: From 2 years before enrollment up to Month 12 (approximately 3 years) ]
  3. Percentage of Participants who Achieved Clinical and Combined Clinical and Endoscopic Remission [ Time Frame: 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.

  4. Percentage of Participants with at least one Episode of Failure of Biological or Non-biological Therapy [ Time Frame: 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.

  5. 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 [ Time Frame: 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.

  6. Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice [ Time Frame: 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.

  7. Percentage of Participants with Hospitalizations due to Complications, IBD related Surgeries, and Disability Determination [ Time Frame: From 2 years before enrollment up to Month 12 (approximately 3 years) ]
  8. Percentage of Participants with Surgical Treatment Based on Indications, Types of Surgeries and Complications [ Time Frame: From 2 years before enrollment up to Month 12 (approximately 3 years) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with moderate to severe UC or CD will be observed both retrospectively and prospectively.
Criteria

Inclusion Criteria:

  1. Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
  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:

  1. Current or previous (within the last two years) indeterminate or not classified colitis.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532932


Locations
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Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Takeda
More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03532932    
Other Study ID Numbers: IBD-5005
U1111-1207-6263 ( Other Identifier: WHO )
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/takeda/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug therapy
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases