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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,990
- Locations
- 34
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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)
- 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))
- Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity(From Baseline Visit (Day 1) up to 12 months)
- 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))
- 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))