Crohn's DiseasePhase 4NCT02324699
Corticosteroids With Vedolizumab in Crohn's Disease
A Phase 4 study testing Prednisone and Vedolizumab in people with Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Prednisone and Vedolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 8 Feb 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at entry 18 to 70
- CDAI score > 220
- Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (>2 weeks from last dose) prior to initiation of vedolizumab.
- Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
- Able to provide written informed consent.
- Patient is planned for or eligible to initiate vedolizumab
Who cannot join
- Concurrent use of anti-TNFα antibodies.
- No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
- No stoma at the time of enrollment
- No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
- Pregnant women or plans for pregnancy within 3 months of study inclusion
- Presence of stoma, more than three small-bowel resections, or documented history of short bowel syndrome
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- Intestinal stricture requiring surgery
- Abdominal abscess
- Inability or unwillingness to provide informed consent
- Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
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.
Read the detailed description
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.
- Conditions
- Crohn's Disease
- Being tested
- Prednisone, Placebo, Vedolizumab
- Keywords
- Vedolizumab, Corticosteroids, Prednisone, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called corticosteroids
PlaceboDrug
VedolizumabDrug
Also called Entyvio
300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Prednisone; Drug: Vedolizumab |
| Placebo | Placebo comparator | Identical placebo taper Receives: Drug: Placebo; Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, week 6, week 10
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: baseline, week 6 and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startApr 2016
- Primary completion8 Feb 2018
- Study completion8 Feb 2018
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Bruce E. Sands, Icahn School of Medicine at Mount Sinai
- Investigators
- Bruce E Sands, MD, MS, Principal investigator, Icahn School of Medicine at Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324699
- Sponsor's protocol ID
- GCO 14-2209
- Status last verified
- Apr 2019
- First submitted
- 19 Dec 2014
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroids as Co-Induction Agents With Vedolizumab in Crohn's Disease: a Double-blind Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT02324699
- Acronym / sponsor ID
- GCO 14-2209
- Conditions
- Crohn's Disease
- Keywords
- Vedolizumab, Corticosteroids, Prednisone, Crohn's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Apr 2016
- Primary completion
- 8 Feb 2018 (actual)
- Study completion
- 8 Feb 2018 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone co-inductive therapy | Experimental | Drug: Prednisone, Drug: VedolizumabPrednisone 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 | Drug: Placebo, Drug: VedolizumabIdentical placebo taper |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age at entry 18 to 70
- CDAI score > 220
- Concomitant azathioprine, methotrexate, or mercaptopurine permitted if dose has been stable for > 8 weeks. Prior anti-TNFα antibody use permitted but must be discontinued (>2 weeks from last dose) prior to initiation of vedolizumab.
- Documented ulceration on colonoscopy done at screening of 3 or more large ulcers or 10 or more aphthous ulcers
- Able to provide written informed consent.
Key exclusion criteria (10 listed)
- Concurrent use of anti-TNFα antibodies.
- No corticosteroids within prior 3 months (other than budesonide controlled ileal release)
- No stoma at the time of enrollment
- No absolute contraindication to systemic corticosteroid use such as hypersensitivity to any part of the formulation, systemic fungal infection, or recent administration of live or live attenuated vaccine within prior two weeks.
- Pregnant women or plans for pregnancy within 3 months of study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: corticosteroids | Drug | Prednisone co-inductive therapy |
| Placebo | Drug | Placebo |
| VedolizumabAlso: Entyvio300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6. | Drug | Placebo, Prednisone co-inductive therapy |
Primary outcome
Crohn's Disease Activity Index (CDAI)
Time frame: 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
3 secondary outcomes
Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: baseline and week 10
Change in C-Reactive Protein (CRP)
Time frame: baseline and week 10
Change in Calprotectin
Time frame: baseline, week 6 and week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce E Sands, MD, MS principal investigator
Icahn School of Medicine at Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone and Vedolizumab in people with Crohn's Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (CDAI) (time frame: baseline, week 6, week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.