Crohn's DiseaseNCT02450513
Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
An observational study of Crohn's Disease, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Adalimumab
- How many people
- 30 participants
- Where
- 2 sitesBelgium
- Study dates
- Mar 2012to 25 May 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are naïve to TNF antagonist treatment and who will be started on adalimumab for treatment of active refractory Crohn's disease. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium).
Who may be able to join
- Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).
- Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l.
- Informed consent.
Who cannot join
- Patients with ulcerative colitis.
- Patients treated in placebo controlled trials.
- Patients unwilling to participate or withdrawing informed consent for this study.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospitals Leuven
Leuven, 3000
AZ Delta
Roeselare, 8800
About this study
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.
Read the detailed description
Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points.
The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission.
This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab
- Keywords
- adalimumab, anti-TNF, pharmacokinetics, trough level, immunogenicity
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards
| Study group | Role | What they receive |
|---|---|---|
| Single-group study | Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in clinical remission
As defined by a Harvey-Bradshaw index ≤4
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMar 2012
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip Baert, MD, Principal investigator, Filip.Baert@azdelta.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450513
- Sponsor's protocol ID
- S53297
- Status last verified
- Jul 2024
- First submitted
- 12 May 2015
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vande Casteele N, Baert F, Bian S, Dreesen E, Compernolle G, Van Assche G, Ferrante M, Vermeire S, Gils A. Subcutaneous Absorption Contributes to Observed Interindividual Variability in Adalimumab Serum Concentrations in Crohn's Disease: A Prospective Multicentre Study. J Crohns Colitis. 2019 Sep 27;13(10):1248-1256. doi: 10.1093/ecco-jcc/jjz050.
PubMed 30820530
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT02450513
- Acronym / sponsor ID
- S53297
- Conditions
- Crohn's Disease
- Keywords
- adalimumab, anti-TNF, pharmacokinetics, trough level, immunogenicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 21 May 2015 (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.
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.
Detailed description
Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points.
The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission.
This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-group study | – | Drug: AdalimumabSubjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are naïve to TNF antagonist treatment and who will be started on adalimumab for treatment of active refractory Crohn's disease. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium).
Key inclusion criteria (3 listed)
- Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).
- Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l.
- Informed consent.
Key exclusion criteria (3 listed)
- Patients with ulcerative colitis.
- Patients treated in placebo controlled trials.
- Patients unwilling to participate or withdrawing informed consent for this study.
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 |
|---|---|---|
| AdalimumabAlso: Humira160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards | Drug | Single-group study |
Primary outcome
Proportion of patients in clinical remission
Time frame: week 12
As defined by a Harvey-Bradshaw index ≤4
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 10 Jul 2024.
- Derived from this study: PubMed 30820530Vande Casteele N, Baert F, Bian S, Dreesen E, Compernolle G, Van Assche G, Ferrante M, Vermeire S, Gils A. Subcutaneous Absorption Contributes to Observed Interindividual Variability in Adalimumab Serum Concentrations in Crohn's Disease: A Prospective Multicentre Study. J Crohns Colitis. 2019 Sep 27;13(10):1248-1256. doi: 10.1093/ecco-jcc/jjz050.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Filip Baert, MD principal investigator
Filip.Baert@azdelta.be
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 3 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: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Proportion of patients in clinical remission (time frame: week 12). 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 NCT02450513, which also lists 1 linked publication.
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 10 Jul 2024.