Crohn's DiseaseOPTIMIZENCT01787786
Improving Treatment of Inflammatory Bowel Diseases Through Better Understanding Infliximab Drug and Antibody Levels
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Western Ontario, Canada.
Trial summary
The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2017
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 patients with Crohn's Disease and 50 patients with Ulcerative Colitis from 10 centres (Canada, United States, Netherlands and Spain).
Who may be able to join
- a diagnosis of CD or UC by usual criteria,
- moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
- a need for treatment with IFX for induction of remission as clinically indicated
- patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.
Who cannot join
- perianal CD exclusively
- disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
- patients with known antibodies to IFX (ADAs) at baseline
- a contraindication to infliximab therapy
- a contraindication to endoscopy
- an ostomy
Show all 10Show fewer
- planned surgery
- evidence of severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease at the discretion of the investigator,
- Pregnancy or breastfeeding,
- treatment with any investigational drug in the past 30 days, or 5 half lives (whichever is longer).
About this study
Official title: Defining and Predicting the Ideal Infliximab Pharmacokinetic Profile Associated With Treatment Efficacy in Patients With Inflammatory Bowel Disease
The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients
Read the detailed description
The use of pharmacokinetic analyses incorporating relevant determinants of the infliximab serum concentration can be used to develop a predictive model that will allow optimized dosing for individual patients.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's Disease, Ulcerative Colitis, Optimal Use of infliximab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Irritable Bowel Disease | Infliximab administered according to current FDA and EMS approved doses and intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease
The primary objective of this study is to define the PK profile of IFX in patients with CD and UC and to determine covariates influencing drug clearance.
Measured: 24 weeks
Secondary outcomes (1)
Quantification of relative strengths of individual determinants of infliximab pharmacokinetics
Assessment of potential interactions between these determinants.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Unable to align the study questions with a complementary trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Feagan, MD, Principal investigator, Robarts Clinical Trials - Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787786
- Sponsor's protocol ID
- RP1207
- Acronym
- OPTIMIZE
- Status last verified
- Dec 2015
- First submitted
- 6 Feb 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
PubMed 16339095Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.
PubMed 12047962Reinisch W, Sandborn WJ, Rutgeerts P, Feagan BG, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Blank M, Lang Y, Johanns J, Colombel JF, Present D, Sands BE. Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies. Inflamm Bowel Dis. 2012 Feb;18(2):201-11. doi: 10.1002/ibd.21697. Epub 2011 Apr 11.
PubMed 21484965Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.
PubMed 19174781Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.
PubMed 16931170
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining and Predicting the Ideal Infliximab Pharmacokinetic Profile Associated With Treatment Efficacy in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01787786
- Acronym / sponsor ID
- OPTIMIZE / RP1207
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Crohn's Disease, Ulcerative Colitis, Optimal Use of infliximab
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to align the study questions with a complementary trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Feb 2013 (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 develop a predictive model that will allow optimized dosing of infliximab for individual patients
Detailed description
The use of pharmacokinetic analyses incorporating relevant determinants of the infliximab serum concentration can be used to develop a predictive model that will allow optimized dosing for individual patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irritable Bowel Disease | – | –Infliximab administered according to current FDA and EMS approved doses and intervals. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with Crohn's Disease and 50 patients with Ulcerative Colitis from 10 centres (Canada, United States, Netherlands and Spain).
Key inclusion criteria (4 listed)
- a diagnosis of CD or UC by usual criteria,
- moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
- a need for treatment with IFX for induction of remission as clinically indicated
- patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.
Key exclusion criteria (10 listed)
- perianal CD exclusively
- disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
- patients with known antibodies to IFX (ADAs) at baseline
- a contraindication to infliximab therapy
- a contraindication to endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease
Time frame: 24 weeks
The primary objective of this study is to define the PK profile of IFX in patients with CD and UC and to determine covariates influencing drug clearance.
1 secondary outcome
Quantification of relative strengths of individual determinants of infliximab pharmacokinetics
Time frame: 24 weeks
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 3 Dec 2015.
- Background: PubMed 16339095Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.
- Background: PubMed 12047962Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.
- Background: PubMed 21484965Reinisch W, Sandborn WJ, Rutgeerts P, Feagan BG, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Blank M, Lang Y, Johanns J, Colombel JF, Present D, Sands BE. Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies. Inflamm Bowel Dis. 2012 Feb;18(2):201-11. doi: 10.1002/ibd.21697. Epub 2011 Apr 11.
- Background: PubMed 19174781Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.
- Background: PubMed 16931170Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.
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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.
Brian Feagan, MD principal investigator
Robarts Clinical Trials - Western University
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Western Ontario, Canada.
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 4 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. 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.
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?
Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01787786, which also lists 5 linked publications.
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 3 Dec 2015.