Ulcerative ColitisPhase 4Test-NoTestNCT01960426
Evaluation of Health Costs and Resource Utilization
A Phase 4 study testing Measurement of drug (Adalimumab/Infliximab) and Intensify treatment with the existing drug in people with Ulcerative Colitis and Crohn's Disease, run by University of Western Ontario, Canada at 1 site in United States.
Trial summary
Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Measurement of drug (Adalimumab/Infliximab) and Intensify treatment with the existing drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 4
- 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
- Males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine.
- Non-pregnant, non-lactating females, 18 years of age or older.
- Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. [defined as a minimum of one year since the last menstrual period]).
- Documented diagnosis of CD or UC.
- Active disease symptoms at visit 1 defined by: a. CD subjects: HBS ~ 6 UC subjects: PMCS ~ 4.
- Current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive to infliximab ).
- A minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the following dose:
- Stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1.
Who cannot join
- Contraindication to the use of either infliximab or adalimumab.
- Current infliximab treatment but not naive to adalimumab or
- Current adalimumab treatment but not naive to infliximab.
- Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w.
- Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w.
- Received any investigational drug within 30 days prior to visit 1.
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- Serious underlying disease other than CD or UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
- History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
- Stools positive for clostridium difficile.
- Pregnant or lactating women.
- Change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1.
- Males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Gastroenterology Associates
Denver, Colorado, 80222
About this study
Official title: A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.
Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
Read the detailed description
The purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Measurement of drug (Adalimumab/Infliximab), Intensify treatment with the existing drug
- Keywords
- Harvey Bradshaw score, Partial Mayo Clinical Score, Infliximab, Adalimumab
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of drug (Adalimumab/Infliximab)Other
Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.
Intensify treatment with the existing drugOther
Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist
| Study group | Role | What they receive |
|---|---|---|
| Empiric Dose Intensification | Active comparator | Intensify treatment with the existing drug Receives: Other: Intensify treatment with the existing drug |
| Testing based strategy | Active comparator | Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement Receives: Other: Measurement of drug (Adalimumab/Infliximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
Analysis of costs and outcomes will be made on an intention-to-treat basis
Measured: 31 weeks
Secondary outcomes (1)
The efficacy of the testing-based strategy compared to empiric dose intensification
The proportion of subjects achieving clinical remission
Measured: 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Prometheus Laboratories
- Responsible party
- Sponsor
- Investigators
- Brian Feagan, MD, Principal investigator, Robarts Clinical Trials Inc. - Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960426
- Sponsor's protocol ID
- RP1208
- Acronym
- Test-NoTest
- Status last verified
- May 2016
- First submitted
- 25 Sep 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.
PubMed 23357488Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. doi: 10.1136/bmj.330.7495.843. No abstract available.
PubMed 15817555Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33; quiz 591. doi: 10.1053/j.gastro.2005.11.030.
PubMed 16472588Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38. doi: 10.1056/NEJMoa067594.
PubMed 17634458
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT01960426
- Acronym / sponsor ID
- Test-NoTest / RP1208
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Harvey Bradshaw score, Partial Mayo Clinical Score, Infliximab, Adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Collaborators
- Prometheus Laboratories
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Oct 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.
Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
Detailed description
The purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empiric Dose Intensification | Active comparator | Other: Intensify treatment with the existing drugIntensify treatment with the existing drug |
| Testing based strategy | Active comparator | Other: Measurement of drug (Adalimumab/Infliximab)Measurement of drug (Adalimumab/Infliximab) Testing-based strategy for the management of secondary loss of response that is based on drug/ ADA measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine.
- Non-pregnant, non-lactating females, 18 years of age or older.
- Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. [defined as a minimum of one year since the last menstrual period]).
- Documented diagnosis of CD or UC.
- Active disease symptoms at visit 1 defined by: a. CD subjects: HBS ~ 6 UC subjects: PMCS ~ 4.
Key exclusion criteria (12 listed)
- Contraindication to the use of either infliximab or adalimumab.
- Current infliximab treatment but not naive to adalimumab or
- Current adalimumab treatment but not naive to infliximab.
- Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w.
- Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w.
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 |
|---|---|---|
| Measurement of drug (Adalimumab/Infliximab)Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug. | Other | Testing based strategy |
| Intensify treatment with the existing drugIntensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist | Other | Empiric Dose Intensification |
Primary outcome
the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms
Time frame: 31 weeks
Analysis of costs and outcomes will be made on an intention-to-treat basis
1 secondary outcome
The efficacy of the testing-based strategy compared to empiric dose intensification
Time frame: 31 weeks
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 23357488Velayos FS, Kahn JG, Sandborn WJ, Feagan BG. A test-based strategy is more cost effective than empiric dose escalation for patients with Crohn's disease who lose responsiveness to infliximab. Clin Gastroenterol Hepatol. 2013 Jun;11(6):654-66. doi: 10.1016/j.cgh.2012.12.035. Epub 2013 Jan 26.
- Background: PubMed 15817555Altman DG, Bland JM. Treatment allocation by minimisation. BMJ. 2005 Apr 9;330(7495):843. doi: 10.1136/bmj.330.7495.843. No abstract available.
- Background: PubMed 16472588Hanauer SB, Sandborn WJ, Rutgeerts P, Fedorak RN, Lukas M, MacIntosh D, Panaccione R, Wolf D, Pollack P. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33; quiz 591. doi: 10.1053/j.gastro.2005.11.030.
- Background: PubMed 17634458Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38. doi: 10.1056/NEJMoa067594.
- Individual participant dataSharing planned: Undecided
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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 Inc. - Western University
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 Measurement of drug (Adalimumab/Infliximab) and Intensify treatment with the existing drug in people with Ulcerative Colitis and Crohn's Disease, run by University of Western Ontario, Canada 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 12 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 13 May 2016. 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. 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?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
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?
the mean difference in cumulative costs (Visit I to Week 3 1) between the two treatment arms (time frame: 31 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 NCT01960426, which also lists 4 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 13 May 2016.