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

Takeda1,990 enrolled

Overview

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: * 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 Type

OBSERVATIONAL

Enrollment

1,990

Conditions

Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (36)

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

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).

Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)

Secondary Outcomes

Number of Participants Stratified by Location of Disease

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Republican Gastroenterology Center, City Clinical Hospital # 10

Minsk, Minsk Oblast, Belarus

Vitebsk regional clinical specialized center

Vitebsk, Vitebsk Oblast, Belarus

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

Almaty, Almaty Region, Kazakhstan

The Centre of Coloproctology based at City Hospital 1

Astana, Astana, Kazakhstan

Regional clinical hospital

Shymkent, Shymkent, Kazakhstan

Regional Clinical Hospital

Barnaul, Altai Territory, 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, Russia

State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical hospital"

Chelyabinsk, Chelyabinsk Oblast, Russia

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

Irkutsk, Irkutsk Oblast, Russia

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

Kemerovo, Kemerovo Oblast, Russia

...and 26 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: From 2 years before enrollment up to Month 12 after enrollment (up to 3 years)