Trial · NCT03532932
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, Takeda; results first posted 2024-03-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice. Trials, record NCT03532932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03532932
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
- NCT number
- NCT03532932
- Status
- Completed
- Enrollment
- 1,990 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- First posted
- 2018-05-22
- Last updated
- 2024-03-29
- Results first posted
- 2024-03-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 | Number of Participants Stratified by Location of Disease | Within 1 year prior to Baseline (Visit 1) | |
| Secondary | Number of Participants Stratified by Disease Severity | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period | 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. |
| Secondary | 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 | 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. |
| Secondary | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | From Baseline Visit (Day 1) up to 12 months | 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. |
| Secondary | 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 | 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. |
| Secondary | 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 | 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. |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Percentage of Participants Stratified by Achieving the Treatment Goals | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | FAS included those participants who signed the informed consent form and were analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Stratified by Location of Disease | Within 1 year prior to Baseline (Visit 1) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Stratified by Disease Severity | At Visit 1 (Baseline), Visit 2 (6 months), Visit 3 (12 months) of prospective period | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | FAS included those participants who signed the informed consent form and were analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity | From Baseline Visit (Day 1) up to 12 months | FAS included those participants who signed the informed consent form and were analyzed in the study. | assessments | MEAN |
| SECONDARY | 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 | FAS included those participants who signed the informed consent form and were analyzed in the study. | percentage of participants | NUMBER |
| SECONDARY | 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 | FAS included those participants who signed the informed consent form and were analyzed in the study. | percentage of participants | NUMBER |
| SECONDARY | 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) | FAS included those participants who signed the informed consent form and were analyzed in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Stratified by Achieving the Treatment Goals | From 2 years before enrollment up to Month 12 after enrollment (up to 3 years) | 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. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group214
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | UC Participants | Greater than (>) 5-aminosalicylic acid (5ASA) 1 | 33 | Participants | |
| 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 | CD Participants | Greater than (>) 5-aminosalicylic acid (5ASA) 1 | 16 | Participants | |
| 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 | UC Participants | >5ASA 2 | 38 | Participants | |
| 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 | CD Participants | >5ASA 2 | 14 | Participants | |
| 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 | UC Participants | > 5ASA 3 | 192 | Participants | |
| 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 | CD Participants | > 5ASA 3 | 30 | Participants | |
| 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 | UC Participants | >5ASA 4 | 9 | Participants | |
| 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 | CD Participants | >5ASA 4 | 5 | Participants | |
| 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 | UC Participants | >5ASA 5 | 46 | Participants | |
| 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 | CD Participants | >5ASA 5 | 7 | Participants |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | UC Participants | 1,214 | |
| Overall Study | STARTED | CD Participants | 687 | |
| Overall Study | COMPLETED | UC Participants | 1,140 | |
| Overall Study | COMPLETED | CD Participants | 615 | |
| Overall Study | NOT COMPLETED | UC Participants | 74 | |
| Overall Study | NOT COMPLETED | CD Participants | 72 |
Source ClinicalTrials.gov
Adverse events194
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | UC Participants | 7 | 1,214 | |
| other | Leukopenia | Blood and lymphatic system disorders | CD Participants | 5 | 687 | |
| other | Bicytopenia | Blood and lymphatic system disorders | UC Participants | 1 | 1,214 | |
| other | Bicytopenia | Blood and lymphatic system disorders | CD Participants | 0 | 687 | |
| other | Gilbert's syndrome | Congenital, familial and genetic disorders | UC Participants | 1 | 1,214 | |
| other | Gilbert's syndrome | Congenital, familial and genetic disorders | CD Participants | 0 | 687 | |
| other | Abdominal pain | Gastrointestinal disorders | UC Participants | 1 | 1,214 | |
| other | Abdominal pain | Gastrointestinal disorders | CD Participants | 0 | 687 | |
| other | Colitis ulcerative | Gastrointestinal disorders | UC Participants | 4 | 1,214 | |
| other | Colitis ulcerative | Gastrointestinal disorders | CD Participants | 0 | 687 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | UC Participants | 3 | 1,214 |
| Total, all-cause mortality | CD Participants | 5 | 687 |
| Total, other adverse events | UC Participants | 48 | 1,214 |
| Total, other adverse events | CD Participants | 31 | 687 |
| Total, serious adverse events | UC Participants | 146 | 1,214 |
| Total, serious adverse events | CD Participants | 84 | 687 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| UC Participants vs CD Participants: Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy | Trial comparisons |
| UC Participants vs CD Participants: deaths from any cause | Trial comparisons |
| UC Participants vs CD Participants: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03532932
GET https://conductscience.org/api/trials/v1/NCT03532932/results?page=2