Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02634060
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2015-12-14
Brief Title:
Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELP-AID
Brief Summary:
Recently a smartphone application IBDoc was developed to enable patients to measure faecal calprotectin at home in an easy way In this HELP-AID trial we want to evaluate the value of these home based IBDoc faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study They will be asked to collect a stool sample at 3 different time points week 0 4 and 8 This faecal sample needs to be loaded on a test cassette with an extraction device In a second step the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp which is based on an immunochromatographic test Finally the CalApp will transmit the test results securely to the health care professional
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc on clinical biological and endoscopic outcome at week 12 Furthermore we want to evaluate the correlation between IBDoc and classical ELISA measurements of faecal calprotectin and the convenience of this system to the patient and the health care professional
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study They will be asked to collect a stool sample at 3 different time points week 0 4 and 8 This faecal sample needs to be loaded on a test cassette with an extraction device In a second step the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp which is based on an immunochromatographic test Finally the CalApp will transmit the test results securely to the health care professional
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc on clinical biological and endoscopic outcome at week 12 Furthermore we want to evaluate the correlation between IBDoc and classical ELISA measurements of faecal calprotectin and the convenience of this system to the patient and the health care professional
Detailed Description:
Adalimumab Humira a fully human monoclonal antibody to TNF has been given an important position in the treatment of patients with an inflammatory bowel disease IBD However not all patients respond adequately to this relatively expensive and potentially toxic therapy Adapting the standard treatment regimen to the individual needs of the patient may favor the short and long term outcome of this therapy
Following daily clinical practice patients will receive standard induction therapy with 160 mg adalimumab at week 0 followed by 80 mg adalimumab at week 2 Starting at week 4 patients will receive a maintenance therapy with 40 mg adalimumab every other week If a patient shows an insufficient response the dose can be increased to 40 mg adalimumab every week
Defining predictors of response to ADA has become a major objective in scientific research One of the predictors of response may be an early decrease in faecal calprotectin Faecal calprotectin is a protein which presence in the stool of a patient correlates with endoscopic disease activity A persistently elevated faecal calprotectin after start up with adalimumab treatment may suggest that this patient needs a higher dose
Recently a smartphone application IBDoc was developed to enable patients to measure faecal calprotectin at home in an easy way In this HELP-AID trial we want to evaluate the value of these home based IBDoc faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study They will be asked to collect a stool sample at 3 different time points week 0 4 and 8 This faecal sample needs to be loaded on a test cassette with an extraction device In a second step the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp which is based on an immunochromatographic test Finally the CalApp will transmit the test results securely to the health care professional
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc on clinical biological and endoscopic outcome at week 12 Furthermore we want to evaluate the correlation between IBDoc and classical ELISA measurements of faecal calprotectin and the convenience of this system to the patient and the health care professional
Following daily clinical practice patients will receive standard induction therapy with 160 mg adalimumab at week 0 followed by 80 mg adalimumab at week 2 Starting at week 4 patients will receive a maintenance therapy with 40 mg adalimumab every other week If a patient shows an insufficient response the dose can be increased to 40 mg adalimumab every week
Defining predictors of response to ADA has become a major objective in scientific research One of the predictors of response may be an early decrease in faecal calprotectin Faecal calprotectin is a protein which presence in the stool of a patient correlates with endoscopic disease activity A persistently elevated faecal calprotectin after start up with adalimumab treatment may suggest that this patient needs a higher dose
Recently a smartphone application IBDoc was developed to enable patients to measure faecal calprotectin at home in an easy way In this HELP-AID trial we want to evaluate the value of these home based IBDoc faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study They will be asked to collect a stool sample at 3 different time points week 0 4 and 8 This faecal sample needs to be loaded on a test cassette with an extraction device In a second step the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp which is based on an immunochromatographic test Finally the CalApp will transmit the test results securely to the health care professional
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc on clinical biological and endoscopic outcome at week 12 Furthermore we want to evaluate the correlation between IBDoc and classical ELISA measurements of faecal calprotectin and the convenience of this system to the patient and the health care professional
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None