Inflammatory Bowel DiseaseNCT02073526
Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Infliximab, adalimumab, certolizumab pegol
- How many people
- 1,230 participants
- Where
- 1 siteNorway
- Study dates
- May 2013to Nov 2016
- How long will I take part?
- 3 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Inflammatory bowel disease treated with anti-TNF drug
Who may be able to join
- Patients diagnosed with Inflammatory bowel disease
- Treated with anti-TNF drug
- Follow-up at specialized gastroenterologist in Norway
- Age 18 or over
Who cannot join
- Patients refusing to participate by not giving their informed consent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, 0424
About this study
Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of medication.
Read the detailed description
Crohn´s disease and ulcerative colitis are diseases where the proinflammatory cytokine Tumor Necrosis Factor-alpha (TNF) plays an important role. Anti-TNF agents are used in the treatment. However, some patients do not respond and response rates declines over time. The cause may be immunogenicity against the agent itself, the agent´s failure to neutralize TNF or another biological pathway leading to inflammation. Anti-TNF agents have been administrated as fixed doses at certain frequencies and this may not be optimal for all patients, but recent studies have indicated a correlation between efficacy and serum drug concentration levels (trough levels). Our preliminary data suggest that trough levels early in the treatment course may be predictive of later trough levels. By multiple measurements, this will be assessed. The study will also investigate biological markers in serum and blood cells which may be predictable for trough levels. Finally, we will compare different methods to measure serum drug concentrations.
- Being tested
- Infliximab, adalimumab, certolizumab pegol
- Keywords
- Antibodies, Monoclonal, Anti-TNF, TNF-alpha, Trough level, Drug concentration, ELISA
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab, adalimumab, certolizumab pegolDrug
Patients are treated with the above mentioned drugs decided by clinicians
| Study group | Role | What they receive |
|---|---|---|
| Anti-TNF | Inflammatory bowel patients age 18 and over treated with anti-TNF agents Receives: Drug: Infliximab, adalimumab, certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of drug serum concentrations
Drug serum concentration will be measured using an ELISA
Measured: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
Secondary outcomes (3)
Measure soluble TNF-receptor in serum
Measured: Measurement will be conducted in 2015 on blood samples stored in a bio-bank
Assay validation
Drug concentration measurements will be conducted with ELISA's with monoclonal and polyclonal antibodies, automated immunofluorometric assay and commercial kits for the purpose to validate tests and establish standards for measurements
Measured: December 2013 - March 2014
Change in individuals drug serum concentration
Intra-individual fluctuations in consecutively measurements during a course of treatment will be measured.
Measured: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionNov 2016
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 Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,230 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Knut E. A. Lundin, Oslo University Hospital
- Investigators
- Knut EA Lundin, Prof., Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073526
- Sponsor's protocol ID
- 2013-1352
- Status last verified
- Dec 2016
- First submitted
- 9 Jan 2014
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02073526
- Acronym / sponsor ID
- 2013-1352
- Keywords
- Antibodies, Monoclonal, Anti-TNF, TNF-alpha, Trough level, Drug concentration, ELISA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Feb 2014 (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.
Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of medication.
Detailed description
Crohn´s disease and ulcerative colitis are diseases where the proinflammatory cytokine Tumor Necrosis Factor-alpha (TNF) plays an important role. Anti-TNF agents are used in the treatment. However, some patients do not respond and response rates declines over time. The cause may be immunogenicity against the agent itself, the agent´s failure to neutralize TNF or another biological pathway leading to inflammation. Anti-TNF agents have been administrated as fixed doses at certain frequencies and this may not be optimal for all patients, but recent studies have indicated a correlation between efficacy and serum drug concentration levels (trough levels). Our preliminary data suggest that trough levels early in the treatment course may be predictive of later trough levels. By multiple measurements, this will be assessed. The study will also investigate biological markers in serum and blood cells which may be predictable for trough levels. Finally, we will compare different methods to measure serum drug concentrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-TNF | – | Drug: Infliximab, adalimumab, certolizumab pegolInflammatory bowel patients age 18 and over treated with anti-TNF agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Inflammatory bowel disease treated with anti-TNF drug
Key inclusion criteria (4 listed)
- Patients diagnosed with Inflammatory bowel disease
- Treated with anti-TNF drug
- Follow-up at specialized gastroenterologist in Norway
- Age 18 or over
Key exclusion criteria (1 listed)
- Patients refusing to participate by not giving their informed consent
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, adalimumab, certolizumab pegolPatients are treated with the above mentioned drugs decided by clinicians | Drug | Anti-TNF |
Primary outcome
Measurement of drug serum concentrations
Time frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
Drug serum concentration will be measured using an ELISA
3 secondary outcomes
Measure soluble TNF-receptor in serum
Time frame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank
Assay validation
Time frame: December 2013 - March 2014
Change in individuals drug serum concentration
Time frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
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 6 Dec 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.
Knut EA Lundin, Prof. principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by Oslo University Hospital at 1 site in Norway.
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 1 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 6 Dec 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 Norway. 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.
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?
Measurement of drug serum concentrations (time frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration). 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 6 Dec 2016.