Crohn DiseaseEarly Phase 1NCT02953275
Synergistic Effect of Vedolizumab and Pentoxifylline
A Early Phase 1 study testing vedolizumab and Pentoxifylline in people with Crohn Disease, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- vedolizumab and Pentoxifylline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2017to 13 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
- Patients who are good candidates to start standard dosing of vedolizumab
- Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
- Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
- Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
- Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening
- Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab
- Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion
Who cannot join
- Contraindications or history of allergy to PTX
- Known interaction of PTX with patient's current medications
- Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
- Pregnancy
- GFR <30 at any time in the 6 months prior to first infusion of VDZ
- Documented cirrhosis
- Age <18 or >80 years old
- Contraindication to colonoscopy at 24 week study time-point
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
About this study
Official title: Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.
- Conditions
- Crohn Disease
- Being tested
- vedolizumab, Pentoxifylline, placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vedolizumabDrug
Also called Entyvio
standard of care
PentoxifyllineDrug
Also called Trental
added to vedolizumab
placeboDrug
added to vedolizumab
| Study group | Role | What they receive |
|---|---|---|
| vedolizumab plus pentoxifylline | Experimental | Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily. Receives: Drug: vedolizumab; Drug: Pentoxifylline |
| vedolizumab plus placebo | Placebo comparator | Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily. Receives: Drug: vedolizumab; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients in clinical remission
Measured: week 14
Secondary outcomes (4)
number of new major and minor infections
Measured: week 24
number of episodes of nephrotoxicity
Measured: week 24
number of episodes of hepatotoxicity
Measured: week 24
number of episodes of myelosuppression
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start13 Apr 2017
- Primary completion18 Mar 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Amar Deshpande, University of Miami
- Investigators
- Amar R Deshpande, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953275
- Sponsor's protocol ID
- 20160543
- Status last verified
- Jul 2019
- First submitted
- 31 Oct 2016
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02953275
- Acronym / sponsor ID
- 20160543
- Conditions
- Crohn Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 18 Mar 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.
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 |
|---|---|---|
| vedolizumab plus pentoxifylline | Experimental | Drug: vedolizumab, Drug: PentoxifyllinePatients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily. |
| vedolizumab plus placebo | Placebo comparator | Drug: vedolizumab, Drug: placeboPatients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
- Patients who are good candidates to start standard dosing of vedolizumab
- Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
- Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
- Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
Key exclusion criteria (8 listed)
- Contraindications or history of allergy to PTX
- Known interaction of PTX with patient's current medications
- Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
- Pregnancy
- GFR <30 at any time in the 6 months prior to first infusion of VDZ
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 |
|---|---|---|
| vedolizumabAlso: Entyviostandard of care | Drug | vedolizumab plus pentoxifylline, vedolizumab plus placebo |
| PentoxifyllineAlso: Trentaladded to vedolizumab | Drug | vedolizumab plus pentoxifylline |
| placeboadded to vedolizumab | Drug | vedolizumab plus placebo |
Primary outcome
proportion of patients in clinical remission
Time frame: week 14
4 secondary outcomes
number of new major and minor infections
Time frame: week 24
number of episodes of nephrotoxicity
Time frame: week 24
number of episodes of hepatotoxicity
Time frame: week 24
number of episodes of myelosuppression
Time frame: week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Amar R Deshpande, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vedolizumab and Pentoxifylline in people with Crohn Disease, run by University of Miami 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients in clinical remission (time frame: week 14). 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 11 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.