No registrations found.
ID
Source
Brief title
Health condition
inflammatory bowel disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients developing Loss of Response (LOR) to IFX or ADL.
Loss of response is a composite endpoint defined as:
1) Stopping IFX or ADL therapy due to worsening symptoms and abnormal endoscopy/imaging/biomarker indicating increased disease activity or
2) Need for addition of corticosteroids, and/or addition immunomodulators (thiopurines or methotrexate), and/or addition of a second biologic due to worsening symptoms and abnormal endoscopy/biomarker results indicating increased disease activity or
3) Increase in fecal calprotectin concentration of ≥100 mg/Gr to a value >250mg/Gr
4) Need for surgery (intestinal resection, fistulotomy, stricturoplasty) due to IBD exacerbation or
5) New or recurring actively-draining fistula or
6) Endoscopic deterioration compared to previous endoscopy – both performed during anti-TNF maintenance treatment – defined by a total SES CD score increase of ≥50% or endoscopic mayo score increase ≥1
Secondary outcome
Time to Loss of Response (LOR) to IFX or ADL
Proportion of patients undergoing treatment optimization using a dose intensification and/or interval decrease/increase.
Background summary
Rationale:
Measurement of infliximab (IFX) and adalimumab (ADL) can be used as an aid in the management of inflammatory bowel disease (IBD).
Objective:
To evaluate the relationship between the Procise IFX Test or Procise ADL test results and changes in the state of the patients’ IBD and to validate the use of the IFX or ADL test for the monitoring of serum levels of IFX or ADL as an aid in the management of IBD.
Study design:
Retrospective observational study.
Observation time:
Observational period starts at the fist available serum sample taken between 2016 and 2018. Patients are required to have a follow up of at least 24 months.
Study population:
Serum samples of 320 adult (≥ 16 years old) patients with a confirmed diagnosis of IBD and treated with maintenance IFX or ADL therapy (160 IFX (including biosimilars) & 160 ADL (including biosimilars)) that were previously collected and stored frozen with ≥ 24 months follow up
Main study parameters/endpoints:
Primary outcome: Proportion of patients developing Loss of Response (LOR) to IFX or ADL
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The entire study is retrospective with no additional risks or burden for participants. However, serum was collected as part of standard medical care and not for research purposes. Hence, written informed consent is obtained to use these serum samples for the objective as specified in this study protocol and to conduct retrospective medical chart review.
Study objective
The hypothesis is that patients with low anti-TNF drug levels have a higher risk of loss-of-response to anti-TNF drugs compared to patients with high anti-TNF drug levels.
Study design
Observational (standard of care)
Observational period starts at the fist available serum sample taken between 2016 and 2018. Patients are required to have a follow up of at least 24 months.
Intervention
not applicable
Inclusion criteria
1. Adult (≥16 years old) Males and females with either CD or UC.
2. Patients must have a confirmed diagnosis of CD or UC based on results of a complete medical evaluation and assessment by a physician specialized in inflammatory bowel disease.
3. Patients must be undergoing maintenance phase IFX or ADL therapy at the time of the first blood collection used for the current study
4. Patients must have at least 24 months of follow up after the baseline sample.
5. Written informed consent must be provided.
Exclusion criteria
1. Patients not undergoing maintenance phase IFX, ADL or biosimilar therapy at time of baseline sample collection.
2. Patients not diagnosed with either CD or UC.
3. Receipt of any blood products within 3 months prior to the baseline sample collection
4. Participation in a clinical trial at the baseline sample collection or within the 8 weeks prior to the baseline sample collection.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8934 |
| Other | METC AMC : W20_314 |