Inflammatory Bowel DiseasePhase 3NCT02771457
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
A Phase 3 study testing Infliximab at weeks 0,2, and 6, Infliximab at weeks 0,4, and 8 and Infliximab at weeks 0 and 8 in people with Inflammatory Bowel Disease, run by NYU Langone Health.
Trial summary
The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Infliximab at weeks 0,2, and 6, Infliximab at weeks 0,4, and 8 and Infliximab at weeks 0 and 8
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years or older who are willing and able to provide informed consent
- HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
- History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
- Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
- Infliximab drug holiday for at least 12 weeks.
Who cannot join
- Inability or unwillingness to provide informed consent
- Pregnant patients
- Prior history of serious infusion reaction to IFX
About this study
The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Infliximab at weeks 0,2, and 6, Infliximab at weeks 0,4, and 8, Infliximab at weeks 0 and 8
- Keywords
- Influximab, IFX, Remicade
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab at weeks 0,2, and 6Drug
Infliximab at weeks 0,4, and 8Drug
Infliximab at weeks 0 and 8Drug
For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab at weeks 0,2, and 6 | Experimental | In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6. Receives: Drug: Infliximab at weeks 0,2, and 6 |
| Infliximab at weeks 0,4, and 8 | Experimental | In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8 Receives: Drug: Infliximab at weeks 0,4, and 8 |
| Infliximab at weeks 0, and 8 | Active comparator | In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8. Receives: Drug: Infliximab at weeks 0 and 8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure Rate
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
Measured: One year
Secondary outcomes (5)
Short-term clinical response
The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.
Measured: One year
Long-term clinical response
The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.
Measured: One year
Short-term changes in patient Quality of Life
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: One Year
Long-term changes in patient Quality of Life
This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Measured: One Year
Fecal calprotectin measurements
This will be measured by ELISA kits
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Chen, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771457
- Sponsor's protocol ID
- 15-01180
- Status last verified
- Jun 2016
- First submitted
- 9 May 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Infliximab Reinduction After Temporary Discontinuation of Drug
- ClinicalTrials.gov ID
- NCT02771457
- Acronym / sponsor ID
- 15-01180
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Influximab, IFX, Remicade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 13 May 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 primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infliximab at weeks 0,2, and 6 | Experimental | Drug: Infliximab at weeks 0,2, and 6In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6. |
| Infliximab at weeks 0,4, and 8 | Experimental | Drug: Infliximab at weeks 0,4, and 8In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8 |
| Infliximab at weeks 0, and 8 | Active comparator | Drug: Infliximab at weeks 0 and 8In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 years or older who are willing and able to provide informed consent
- HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.
- History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.
- Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals
- Infliximab drug holiday for at least 12 weeks.
Key exclusion criteria (3 listed)
- Inability or unwillingness to provide informed consent
- Pregnant patients
- Prior history of serious infusion reaction to IFX
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 |
|---|---|---|
| Infliximab at weeks 0,2, and 6 | Drug | Infliximab at weeks 0,2, and 6 |
| Infliximab at weeks 0,4, and 8 | Drug | Infliximab at weeks 0,4, and 8 |
| Infliximab at weeks 0 and 8For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks. | Drug | Infliximab at weeks 0, and 8 |
Primary outcome
Failure Rate
Time frame: One year
Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.
5 secondary outcomes
Short-term clinical response
Time frame: One year
Long-term clinical response
Time frame: One year
Short-term changes in patient Quality of Life
Time frame: One Year
Long-term changes in patient Quality of Life
Time frame: One Year
Fecal calprotectin measurements
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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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.
Lea Chen principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infliximab at weeks 0,2, and 6, Infliximab at weeks 0,4, and 8 and Infliximab at weeks 0 and 8 in people with Inflammatory Bowel Disease, run by NYU Langone Health.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Failure Rate (time frame: One year). 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 30 Jun 2016.