Trial Outcomes & Findings for Corticosteroids With Vedolizumab in Crohn's Disease (NCT NCT02324699)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

baseline, week 6, week 10

Results posted on

2019-04-26

Participant Flow

Study opened in August 2015,and one participant enrolled almost a year later.

Study is double blind and unknown which arm participant was randomized into. Study was never unblinded.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study study terminated	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prednisone Co-inductive Therapy n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants

PRIMARY outcome

Timeframe: baseline, week 6, week 10

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

Outcome measures

Outcome measures
Measure	Prednisone Co-inductive Therapy n=1 Participants 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.
Crohn's Disease Activity Index (CDAI) Baseline	263 score on a scale
Crohn's Disease Activity Index (CDAI) Week 6	112.6 score on a scale
Crohn's Disease Activity Index (CDAI) Week 10	137.5 score on a scale

SECONDARY outcome

Timeframe: baseline and week 10

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.

Outcome measures

Outcome measures
Measure	Prednisone Co-inductive Therapy n=1 Participants 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.
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) Baseline	24 score on a scale
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) Week 10	18 score on a scale

SECONDARY outcome

Timeframe: baseline and week 10

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.

Outcome measures

Outcome measures
Measure	Prednisone Co-inductive Therapy n=1 Participants 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.
Change in C-Reactive Protein (CRP) baseline	11.0 mg/L
Change in C-Reactive Protein (CRP) week 10	43.0 mg/L

SECONDARY outcome

Timeframe: baseline, week 6 and week 10

Population: data not collected

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.

Outcome measures

Outcome data not reported

Adverse Events

Prednisone Co-inductive Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bruce Sands

Icahn School of Medicine at Mount Sinai

Phone: 212-241-8100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place