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Difficult recruitment
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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Use of co-induction with corticosteroid therapies may accelerate the remission rate when used with vedolizumab. Further, this may lead to higher rates of response and remission at week 10 than would be seen with vedolizumab monotherapy.
This study will examine prednisone co-induction with vedolizumab in patients with Crohn's disease. To address questions regarding the effect of co-induction on mucosal healing, the study will include colonoscopic assessment of mucosal healing. Finally, colonic biopsies in this study will allow to elucidate further the mechanism of action of vedolizumab in Crohn's disease through immune phenotyping studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone co-inductive therapy | Experimental | Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5 |
|
| Placebo | Placebo Comparator | Identical placebo taper |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's Disease Activity Index (CDAI) | Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores | baseline, week 6, week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) | The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce E Sands, MD, MS | Icahn School of Medicine at Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Study is double blind and unknown which arm participant was randomized into. Study was never unblinded.
Study opened in August 2015,and one participant enrolled almost a year later.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone Co-inductive Therapy | Prednisone vs Identical placebo taper Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5 Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone Co-inductive Therapy | Prednisone vs Identical placebo taper Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5 Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Crohn's Disease Activity Index (CDAI) | Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores | Posted | Number | score on a scale | baseline, week 6, week 10 |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone Co-inductive Therapy | Prednisone vs Identical placebo taper Prednisone 40 mg/day starting at week 0 for 2 weeks, tapered by 10 mg weekly to achieve 0 mg by end of week 5 Vedolizumab: 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6. |
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Study terminated due to enrollment difficulty.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce Sands | Icahn School of Medicine at Mount Sinai | 212-241-8100 | bruce.sands@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2016 | Apr 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D000305 | Adrenal Cortex Hormones |
| C543529 | vedolizumab |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| Vedolizumab | Drug | 300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6. |
|
|
| baseline and week 10 |
| Change in C-Reactive Protein (CRP) | Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. | baseline and week 10 |
| Change in Calprotectin | Comparison of absolute change in calprotectin from baseline to week 6. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines. | baseline, week 6 and week 10 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) | The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity. | Posted | Number | score on a scale | baseline and week 10 |
|
|
|
| Secondary | Change in C-Reactive Protein (CRP) | Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body. | Posted | Number | mg/L | baseline and week 10 |
|
|
|
| Secondary | Change in Calprotectin | Comparison of absolute change in calprotectin from baseline to week 6. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines. | data not collected | Posted | baseline, week 6 and week 10 |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D007410 | Intestinal Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |